News Articles February 2022

Written on 04 February 2022.

Xeris Biopharma Announces FDA Grants Orphan-drug Exclusivity for Recorlev®

January 30, 2023


CHICAGO–(BUSINESS WIRE)–Jan. 30, 2023– Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that the Food and Drug Administration (FDA) granted its subsidiary Xeris Pharmaceuticals, Inc., orphan-drug exclusivity (ODE) for Recorlev® (levoketoconazole) for the treatment of adult patients with endogenous Cushing’s syndrome for whom surgery is not an option or has not been curative.


As the first approval of levoketoconazole (Recorlev) for Cushing’s syndrome, Xeris is entitled to seven years of orphan-drug market exclusivity from its FDA approval date of December 30, 2021. The FDA’s Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually. This regulatory exclusivity is in addition to the patent exclusivity under Xeris’ U.S. patents covering Recorlev and its therapeutic use, which extends to at least March 2040.


“Cushing’s syndrome is a rare disease that can be physically and emotionally devastating to the patient. Most patients endure years of symptoms prior to obtaining a diagnosis and are then faced with limited effective treatment options,” said Paul R. Edick, Xeris’ Chairman and CEO. “We are excited to receive this important orphan-drug exclusivity approval for Recorlev on a new therapeutic option that can address symptoms while treating the root cause of the disease for this underserved Cushing’s patient community.” 


Mr. Edick continued, “Recorlev is an important and welcome therapeutic option for clinicians to help manage patients with endogenous Cushing’s syndrome, a severe, potentially life-threatening rare disease. The approval of Recorlev was based upon data from two positive Phase 3 studies that evaluated a combined study population of 166 patients and was shown to be effective for reducing and normalizing cortisol.”


In order to serve and support this community, Xeris is committed to ensuring everyone who needs access to their therapies will receive it. Xeris hascreated Xeris CareConnection™ to provide a comprehensive program for patients and their caregivers throughout the treatment journey, includingfinancial assistance, one-on-one support, and educational resources. Xeris CareConnection also supports healthcare professionals and their teams through education on access and reimbursement. For more information visit our website (www.recorlev.com) or contact Xeris CareConnection (available Monday–Friday from 8 a.m–7 p.m ET) at 1-844-444-RCLV (7258).Xeris Biopharma Announces FDA Grants Orphan-drug Exclusivity for Recorlev®

PNA Highlights February 2023

Give a man health and a course to steer, and he’ll never stop to trouble about whether he’s happy or not.

-George Bernard Shaw

In Memorium:

Justin Schultz Cetas, MD, PhD

Oct. 3, 1970 – July 13, 2022

PNA Spotlight: Tyler J. Kenning

This month the PNA Spotlight focuses on Tyler J. Kenning, MD, FAANS, who serves as director of pituitary and cranial base surgery at Piedmont Brain Tumor Center, part of Piedmont Atlanta Hospital. Dr. Kenning attended medical school at Thomas Jefferson University, graduating in 2005. He did his residency at Albany Medical Center in neurological surgery and completed a fellowship in neurosurgical oncology at Thomas Jefferson University Hospital. Here are Dr. Kenning’s answers to a series of questions posed by the PNA.

PNA Medical Corner: When Pituitary Carcinoma Spreads to the Cervical Spine

This month the PNA Medical Corner focuses on a study co-authored by longtime PNA member Dr. William Couldwell. It presents a case study of a woman whose prior pituitary carcinoma spread to the cervical spine. They conclude that long term monitoring of hormones after pituitary surgery is crucial.

Featured News and Updates

Research Articles

Copyright © 2024 Pituitary Network Association All rights reserved.

Disclaimer: PNA does not engage in the practice of medicine. It is not a medical authority, nor does it claim to have medical expertise. In all cases, PNA recommends that you consult your own physician regarding any course of treatment or medication.

Our mailing address is:
Pituitary Network Association
P.O. Box 1958
Thousand Oaks, CA 91358
(805) 499-9973 Phone - (805) 480-0633 Fax
Email [email protected]

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February 2023 Research Articles

Pituitary Tumors

MRI-based brain tumor detection using convolutional deep learning methods and chosen machine learning techniques.

Cathepsin D Inhibits Angiogenesis in Pituitary Neuroendocrine Tumors.

Pituitary adenoma “pneumo-apoplexy”.

Improved Detection of Cavernous Sinus Invasion of Pituitary Macroadenomas with Ultra-High-Field 7 T MRI.

Risk Factor and Replacement Therapy Analysis of Pre- and Postoperative Endocrine Deficiencies for Craniopharyngioma.

The Morphology of the Pituitary Gland: A Meta-Analysis with Implications for Diagnostic Imaging.

Pituitary Surgery

Preoperative frailty status measured by Clinical Risk Analysis Index and adverse events after endoscopic endonasal transsphenoidal resection of pituitary adenoma: results of a single center prospective case series.

Closure strategy for endoscopic pituitary surgery: Experience from 3015 patients.

Pre-Surgery Patient Health Contributes to Aggravated Sino-Nasal Outcome and Quality of Life after Pituitary Adenomectomy.

Clinical Applicability of the Sellar Barrier Concept in Patients with Pituitary Apoplexy: Is It Possible?

Pituitary Cancer

Case Report: Pituitary metastasis as a presenting manifestation of silent gastric cardia adenocarcinoma.

COVID and the Pituitary

The pituitary gland in SARS-CoV-2 infections, vaccinations, and post-COVID syndrome.

Cushing’s

Advances in Molecular Pathophysiology and Targeted Therapy for Cushing’s Disease.

 

News Articles February 2023

Bones of 18th Century Acromegalic Taken Off Museum Display

Photo courtesy of the Queen Mary University of London.

The bones of an 18th century acromegalic Irish man named Charles Byrne were on display as a medical curiosity for 140 years before being taken off display, in accordance with his last wishes. Byrne was almost 8 feet tall when he died in 1783 and had requested a burial at sea, however a friend sold his body to a surgeon named John Hunter. It eventually ended up on display at the Hunterian Museum, which is affiliated with the Royal College of Surgeons of England. Read more:

 

 

Transsphenoidal Pituitary Neurosurgery: A Moment by Moment Account

Dr. Mazda Turel, a neurosurgeon in Mumbai, India, tells the story of a transsphenoidal surgery he performed. He explains each step in a drama with perilous twists and turns. Read more:

Cushing’s Case Report: Severe Infection and Electrolyte Imbalance

An article in Cushing’s Disease News looks at the case of an 82-year-old woman who presented with a severe muscle infection and an imbalance of electrolytes. She was diagnosed with Cushing’s but passed away from infectious complications from a surgery before she could be treated for Cushing’s. Read more:

11-year-old Patient Battles Tumor Pressing on Pituitary

An article in Spring Advertiser.co tells the story of an 11-year-old girl who is battling optic nerve hypoplasia – and has a schwannoma pressing on her pituitary. Read more:

PNA Medical Corner: When Pituitary Carcinoma Spreads to the Cervical Spine

This month the PNA Medical Corner focuses on a study co-authored by longtime PNA member Dr. William Couldwell. It presents a case study of a woman whose prior pituitary carcinoma spread to the cervical spine. They conclude that long term monitoring of hormones after pituitary surgery is crucial.

Link:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844525/

Natural history of pituitary carcinoma with metastasis to the cervical spine: illustrative case

Nicholas T GamboaChristopher WilkersonBornali KunduBrandon A SherrodAndrew T DaileyWilliam T Couldwell

Free PMC article

Abstract

Background: Pituitary carcinoma is a rare tumor of the adenohypophysis with noncontiguous craniospinal dissemination and/or systemic metastases. Given the rarity of this malignancy, there is limited knowledge and consensus regarding its natural history, prognosis, and optimal treatment.

Observations: The authors present the case of a 46-year-old woman initially treated with invasive prolactin-secreting pituitary macroadenoma who developed metastatic disease of the cervical spine 6 years later. The patient presented with acutely worsening compressive cervical myelopathy and required posterior cervical decompression, tumor resection, and instrumented arthrodesis for posterolateral fusion.

Lessons: This case underscores the importance of long-term monitoring of hormone levels and having a high clinical suspicion for metastatic disease to the spine in patients presenting with acute myelopathy or radiculopathy in the setting of previously treated invasive secreting pituitary adenoma.

Keywords: cervical myelopathy; intradural extramedullary mass; pituitary carcinoma; prolactinoma; spinal metastases; spine tumor.

Dr. William Couldwell

PNA Spotlight: Dr. Tyler J. Kenning

This month the PNA Spotlight focuses on Tyler J. Kenning, MD, FAANS, who serves as director of pituitary and cranial base surgery at Piedmont Brain Tumor Center, part of Piedmont Atlanta Hospital. Dr. Kenning attended medical school at Thomas Jefferson University, graduating in 2005. He did his residency at Albany Medical Center in neurological surgery and completed a fellowship in neurosurgical oncology at Thomas Jefferson University Hospital. Here are Dr. Kenning’s answers to a series of questions posed by the PNA.

What inspired you to choose your career path?

My father was a neurosurgeon. Growing up, I watched him work tirelessly, and I quickly realized that his efforts truly embodied the virtues of Theodore Roosevelt’s sentiment that “…the best prize that life has to offer is the chance to work hard at work worth doing.” The potential ability to make a meaningful difference in patients’ lives led me to similarly pursue a career in medicine and then neurosurgery. During my training, I became greatly interested in the physiology of the pituitary gland and the endocrine system as well as endoscopic ‘minimally invasive’ neurosurgery. The prospect of having a brain tumor and then undergoing a neurosurgical procedure is a very daunting and scary one for patients, and the ability to offer ‘minimally invasive’ but ‘maximally effective’ surgery to treat these problems is important.

What is the primary focus of your work/research?

I’m very interested in cranial base surgery and neurosurgical oncology. Both of these are rapidly evolving fields where new technologies are constantly being applied to make treatment more effective, safer, and less destructive to normal structures. My work and research focuses on ways to do that, including minimally invasive surgical approaches and reconstruction of the cranial base. Endoscopic endonasal surgery may be one of the most important recent advances to these fields, allowing safe access to areas of the cranial base and brain that were not previously achievable. In doing so, knowledge of the relevant anatomy, surgical technique and sufficient reconstruction is critical. We have worked and published on each of these areas.

What do you consider to be the future of your field?

Although surgical treatment will likely always be an integral part of cranial base disorders, pituitary care and neuro-oncology, its focus continues to drastically change. We’ve developed safer surgical techniques as well as complementary medical and radiotherapy treatments that allow for more effective therapies and better quality of life for patients. This requires continued evolution of our surgical procedures with a focus not only on treating a tumor and its effects, but also on preserving/restoring function and being minimally disruptive to patient’s lives. Our surgical treatments will continue to be more gentle and safe, while our collaboration in physician ‘teams,’ including medicine, surgery and radiation, will be increasingly important. In the future, there will continue to be a shift away from a ‘single doctor approach’ to management of medical issues in favor of Centers of Excellence and multidisciplinary, collaborative teams of physicians.

What should patients know about your field/what deserves more recognition/awareness?

Being diagnosed with a brain tumor and going to see a neurosurgeon can be a frightening experience for patients. Disorders of the pituitary gland, the ‘master gland’ of our hormone system, is very common and occur in up to 20% of the population. One of the main reasons that I enjoy treating patients with pituitary tumors and problems is that I am able to reassure them that these are typically benign ‘non-cancerous’ tumors, and most patients will be relieved to hear that they just need to be observed (and not necessarily treated) by a team of surgeons, endocrinologists and ophthalmologists. For those patients that do require treatments, these are often highly effective, very safe and allow for rapid recovery.

What would you like to convey about yourself to your patients?

My approach, and that of our entire team, to patients is to provide the care that we would want delivered to ourselves and to members of our own families. Although I am often asked what are my favorite surgical procedures to perform, the preferred aspect of our work is the personal interaction with patients, the reassurance that I am able to provide in the outpatient office and hospital or around the time of surgery and recovery. The ability to make a meaningful difference to patients is the best part of doing what we do. The trust that patients place in us to provide their medical care is such a privilege and one that we recognize and take very seriously

Why did you get involved with the PNA; what is the extent of your involvement.

The PNA is a fantastic patient-centric resource for information on disorders of the pituitary gland. As an international non-profit organization, it has served to bring some of the world’s top clinicians and scientists together in a collaborative effort to improve pituitary care and be at the forefront of supporting research and providing education to patients and their families. The PNA truly embraces the multidisciplinary management of the field, and it is my privilege to be involved and contribute to these efforts..

PNA Highlights January 2023

Cheerfulness is the best promoter of health and is as friendly to the mind as to the body

-Joseph Addison

PNA Spotlight: Dr. Brian Williams

This month the PNA Spotlight focuses on Dr. Brian Williams, an Assistant Professor in the Department of Neurosurgery at the University of Louisville, where he leads the Division of Neurosurgical Oncology, Skull Base Surgery and Pituitary Surgery.  Dr. Williams earned his medical degree from the Baylor College of Medicine in Houston, Texas. He did a residency in neurological surgery at the University of Virginia in Charlottesville, followed by a fellowship in Neurosurgical Oncology at MD Anderson Hospital in Houston.  He also pursued specialty training in cerebrovascular and skull base surgery at the Auckland City Hospital in New Zealand.  He was kind enough to answer some questions from the PNA. His answers are below

Dr. Brian Williams

PNA Medical Corner: Otolaryngology Pioneers of Transsphenoidal Surgery

This month the PNA Medical Corner focuses on an article co-authored by Dr. Edward Laws, a longtime member of the PNA. The research looks at the considerable impact two early otolaryngologists, Markus Hajek and Oskar Hirsch, had in developing endonasal transsphenoidal pituitary surgery. 

Dr. Edward Laws

Featured News and Updates

Research Articles

Copyright © 2024 Pituitary Network Association All rights reserved.

Disclaimer: PNA does not engage in the practice of medicine. It is not a medical authority, nor does it claim to have medical expertise. In all cases, PNA recommends that you consult your own physician regarding any course of treatment or medication.

Our mailing address is:
Pituitary Network Association
P.O. Box 1958
Thousand Oaks, CA 91358
(805) 499-9973 Phone - (805) 480-0633 Fax
Email [email protected]

You are receiving this Newsletter because you have shown interest in receiving information about our activities.

If you do not want to receive any more emails from PNA, Unsubscribe.

January 2023 Research Articles

Pituitary Tumors

Attention and working memory in patients with prolactinomas: a case-control study.

Collision of Two Tumors: A Case Report of a Lung Adenocarcinoma With Metastasis to a Pituitary Adenoma.

The Effect of Prolactinoma on Tear Film Function.

Contemporary Biological Insights and Clinical Management of Craniopharyngioma.

Radiation therapy outcomes of patients with pituitary macroadenoma.

The need to shed light on potential insidious SARS-CoV-2 post-vaccination pituitary lesions.

Pituitary Surgery

Disparities in Postoperative Endocrine Outcomes After Endoscopic-Assisted Transsphenoidal Pituitary Adenoma Resection.

Multi-layer reconstruction of skull base after endoscopic transnasal surgery for invasive pituitary adenomas.

Clinical outcomes of benign brain tumors treated with single fraction LINAC-based stereotactic radiosurgery: Experience of a single institute.

Acromegaly

Associations between paraclinical parameters, symptoms and quality of life in patients with acromegaly: a cross sectional study.

Case report: Clinical and single-cell transcriptome sequencing analysis of a mixed gangliocytoma-adenoma presenting as acromegaly.

Hormonal Health

Isolated growth hormone deficiency and amenorrhea – Case report

Approach to a case with an unusual cause of hypopituitarism.

 

News Articles January 2023

Doctor Notices Symptoms of Acromegaly in Patient’s Wife

A story in the Times of India explains how a neurologist, treating a patient for back pain, noticed some changes in the patient’s wife’s face. The wife had accompanied her husband to his appointment, and the doctor noticed that her nose and lips appeared larger, and her teeth more spaced out. He asked if her shoe size had gotten bigger, and when she answered in the affirmative he sent her for tests, which revealed that she had harbored a tumor for two years. he Mayo Clinic has produced a podcast with frequently asked questions on pituitary tumors. Check it out here

Tips on Getting Through Your First Brain MRI

A column in Cushing’s Disease News goes through what to expect during a brain MRI, and how to calm your nerves. Read more:

Does the Pituitary Help People Wake Up Just Before the Alarm?

A story on NPR looks at whether people can train themselves to wake up just before the alarm and the role the pituitary might play. It cites one study from the 90s that did find that when people were expecting to wake up at a certain time, their pituitary released ACTH about an hour before the wake time, which stimulates the adrenals to release cortisol, which helps wake people up.. Read more:

Florida 10-year-old Battles Cancer on Pituitary Gland

A story on CBS Miami follows a 10-year-old girl in Homestead, Florida who is fighting mixed germ cell cancer that is taking over her pituitary gland. Her little brother shaved his head in solidarity.  Read more: 

Acromegalic, Known as World’s Tallest Man, Turns 40

Acromegalic Sultan Kosen, who is known as the world’s tallest man at 8’3”, has turned 40 . He traveled from Turkey to Orlando to visit an exhibit about Robert Wadlow, who was 8’11” when he passed away at age 22 in 1940. Modern medical advances have helped many acromegalics lead long lives.  Read More:

Pituitary Journey: Soccer Star Lionel Messi

An article on News9Live.com explains that international soccer star Lionel Messi suffered from pituitary dwarfism as a child and received growth hormone injections that allowed him to pursue his athletic dreams. Read more: 

 

December 2022 Research Articles – Preview

Pituitary Tumors

Classification Framework for Medical Diagnosis of Brain Tumor with an Effective Hybrid Transfer Learning Model.

Prognostic Factors for Invasiveness and Recurrence of Pituitary Adenomas: A Series of 94 Patients.

Classification of Brain Tumor from Magnetic Resonance Imaging Using Vision Transformers Ensembling.

Radiation Therapy for Recurrent or Residual Pituitary Macroadenoma Invading Extrasellar Structures.

A retrospective cohort study assessing geometrical parameters related to visual deterioration in pituitary macroadenoma

Diagnostic value of magnetic resonance imaging ectopic posterior pituitary hyperintense signal in pituitary macroadenoma.

Proteogenomic landscape and clinical characterization of GH-producing pituitary adenomas/somatotroph pituitary neuroendocrine tumors.

Available Now!

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