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.”
https://www.biospace.com/article/fda-action-alert-foamix-immunomedics-and-merck/
