The U.S. Food and Drug Administration (FDA) is reviewing an application from Strongbridge Biopharma seeking the approval of Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome

By Marisa Wexler MS on May 14, 2021

The U.S. Food and Drug Administration (FDA) is reviewing an application from Strongbridge Biopharma seeking the approval of Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome.

 

A final decision from the FDA is expected by Jan. 1, 2022 — meaning that Recorlev’s approval request will follow the standard 10-month review period.

Strongbridge was notified of the action target date in an official letter from the U.S. regulatory agency, which was issued earlier than expected.

“We are pleased with the FDA’s acceptance for filing of the Recorlev (levoketoconazole) new drug application,” John H. Johnson, Strongbridge’s CEO, said in a press release.

“We are advancing our commercial readiness plans and look forward to potentially bringing a new therapeutic option to the Cushing’s syndrome community in the first quarter of 2022,” Johnson said.

Endogenous Cushing’s syndrome is caused by abnormally high levels of the stress hormone cortisol, usually due to the presence of a benign tumor in the brain’s pituitary gland or in the adrenal glands, which sit atop the kidneys. Recorlev is designed to block cortisol production in the adrenal glands.

Strongbridge submitted a new drug application (NDA) for Recorlev in March. According to the company, the FDA’s letter notifying that the NDA had been accepted for review did not mention a plan to hold an advisory committee meeting.

The company’s NDA submission was mainly supported by data from two Phase 3 studies: SONICS (NCT01838551) and LOGICS (NCT03277690).

SONICS enrolled and treated 94 people with endogenous Cushing’s, with promising results. Specifically, 30% of participants saw their cortisol levels normalize after six months of treatment with Recorlev, without requiring any dose increments during that period.

LOGICS enrolled participants from SONICS, as well as additional patients, and evaluated the effects of Recorlev withdrawal. The results indicated that withdrawing the investigational treatment caused patients’ urinary cortisol levels to rise.

Findings from these trials also have indicated that treatment with Recorlev can lower the risk of heart disease, ease symptoms, lower cholesterol levels and body fat, and help control diabetes in people with endogenous Cushing’s syndrome.

Quality of life was found to be improved and depression lessened after treatment with Recorlev.

The NDA also included safety data from the ongoing, open-label OPTICS trial (NCT03621280), in which participants from previous studies will continue receiving Recorlev for up to three years.

According to Johnson, the FDA’s decision to review the NDA for Recorlev, “reflects the comprehensive clinical evidence that went into the NDA submission, including the positive and statistically significant efficacy and safety results from the multinational Phase 3 SONICS and LOGICS studies evaluating Recorlev as a potential treatment option for adults with endogenous Cushing’s syndrome.”

 

Print

Available Now!

PPRG6-500 Cover
The Pituitary Patient Resource Guide Sixth Edition is now available! Be one of the first to have the most up-to-date information. The Pituitary Patient Resource Guide a one of a kind publication intended as an invaluable source of information not only for patients but also their families, physicians, and all health care providers. It contains information on symptoms, proper testing, how to get a diagnosis, and the treatment options that are available. It also includes Pituitary Network Association's patient resource listings for expert medical care.

Buy Now

  • CalendarPNAJune

    images/CalendarPNASept.png

Continuing Education Program

Knowledge Icon 500

If you are a nurse or medical professional, register for PNA CEU Membership and  earn CEU credits to learn about the symptoms, diagnosis and treatment options for patients with pituitary disorders. Help PNA reduce the time it takes for patients to get an accurate diagnosis.

button registerNow

For more information click here!