FDA Action Alert: Foamix, Immunomedics and Merck


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Although the U.S. Food and Drug Administration (FDA) is very busy dealing with emergency use approvals for diagnostics and possible treatments for COVID-19, it is still evaluating and approving therapies for non-COVID-19 indications. Here’s a look at this week’s calendar.

Foamix’s FMX103 for Rosacea

Foamix, now a subsidiary of Menlo Therapeutics, had a target action date of June 2, 2020 for FMX103, a topical treatment for moderate-to-severe papulopustular rosacea. The FDA approved it on Friday, May 29, under the brand name Zilxi.

 On February 18, the company announced integrated efficacy data on the two pivotal Phase III trial of FMX103 (minocycline, 1.5% foam). Those studies compared FMX103 to vehicle, which is essentially a placebo. The studies were identical with 1,522 subjects, and 1,009 received FMX103 and 513 received vehicle. The data evaluated the results after 12 weeks of once-a-day application.

In the combined analysis, FMX103 showed statistically significant benefit compared to vehicle foam on both primary endpoints, which were reduction of inflammatory lesion counts from Baseline to Week 12 and IgA treatment success defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement at Week 12.

Papulopustular rosacea is a chronic skin disease causing inflammatory lesions on the nose, cheeks, chin and forehead.

“This is the only product containing minocycline approved by the FDA for rosacea,” said Iain Stuart, Menlo’s chief scientific officer. “The availability of a novel topical formulation of this molecule underscores our efforts to provide innovative treatment options for patients who suffer from difficult to treat skin conditions.”

The Foamix and Menlo merger completed on March 9. Foamix’s management team will run the company, led by David Domzalski as chief executive officer.

Immunomedics’ Sacituzumab Govitecan for Triple-Negative Breast Cancer

Immunomedics had a target action date of June 2 for its resubmitted Biologics License Application (BLA) for sacituzumab govitecan for treatment of patients with metastatic-negative breast cancer (mTNBC) who received at least two previous therapies for metastatic disease. The FDA approved the drug on April 22 under the name Trodelvy. It is the first antibody-drug conjugate (ADC) approved by the FDA specifically for relapsed or refractory mTNBC and also the first FDA-approved anti-Trop-2 ADC.

The drug was granted Breakthrough Therapy Designation and Priority Reviews. It was approved under the agency’s Accelerated Approval Program based on the objective response rate (ORR) and duration of response (DoR) observed in a single-arm, multicenter Phase II trial. Continued approval is based in verification of clinical benefit in the confirmatory Phase III ASCENT trial, which was recently halted by the independent Data Safety Monitoring Committee after compelling evidence of efficacy was observed across multiple endpoints.

“The approval of Trodelvy, the first ADC approved specifically for metastatic TNBC, an aggressive cancer with a poor prognosis and few effective therapies, will give clinicians a novel tool for treating patients with this disease,” said Aditya Bardia, director of Precision Medicine at the Center for Breast Cancer, Massachusetts General Hospital Cancer Center and assistant professor of Medicine at Harvard Medical School. Bardia was the lead investigator of the Phase II trial.

Bardia went on to say, “In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle towards better outcomes for patients with metastatic breast cancer.”

Merck’s Recarbrio for Bacterial Pneumonia

Merck has a target action date of June 4 for its supplemental New Drug Application (sNDA) for Recarbrio (imipenem, cilastatin, and relebactam) for adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain susceptible Gram-negative microorganisms. The submission was built on data from the pivotal Phase III RESTORE-IMI 2 trial in adults with HABP/VABP.

The drug was originally approved in July 2019 by the FDA for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis and complicated intra-abdominal infections (cIAI) caused by susceptible Gram-negative bacteria in adults with limited or no alternative treatment options.

“This submission reinforces Merck’s continued dedication to researching and developing potential antibiotic treatment options which address unmet medical needs,” said Nicholas Kartsonis, senior vice president, clinical research, infectious diseases and vaccines, Merck Research Laboratories, in a February 2020 announcement. “We are unwavering in our commitment to evaluate treatments for infections caused by certain Gram-negative pathogens.”

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