FDA Action Alert: 4 Companies with FDA Decisions This Week

FDA

There are several companies facing decisions by the U.S. Food and Drug Administration (FDA) this upcoming week. However, it should be noted that because the upcoming weekend is the Memorial Day holiday in the United States, some of these decisions may be made before their dates to avoid the holiday. Here’s a look.

Dova Pharmaceuticals.

On Monday, May 21, the FDA is expected to make a decision on Dova Pharmaceuticals' New Drug Application (NDA) for avatrombopag for thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. The submission was built on two identically-designed Phase III clinical trials, ADAPT 1 and 2. Avatrombopag met all primary and secondary endpoints with high statistical significance.

The application was accepted under a Priority Review status, which moved the review time from 10 months to a goal of six months. The drug is a second generation orally administered TPO-RA.

In a November 2017 statement, Alex Sapir, president and chief executive officer of Dova, said, “We are extremely pleased that FDA has accepted our NDA submission with Priority Review. We believe that avatrombopag represents a novel treatment option with robust efficacy as well as an improved safety profile when compared to platelet transfusions, today’s current standard of care. We look forward to working closely with FDA through the review process.”

BioMarin Pharmaceutical.

BioMarin, headquartered in San Rafael, California, is awaiting an FDA decision on its Biologics License Application (BLA) for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product to treat adults with phenylketonuria (PKU) who have problems controlling their blood phenylalanine levels despite previous treatment with available therapeutics, including sapropterin. The PDUFA goal date is Friday, May 25.

The drug is also being evaluated by the European Medicines Agency (EMA). In a March 28 statement, Hank Fuchs, president of worldwide research and development for BioMarin, said, “The acceptance of the pegvaliase application for review by the EMA signifies a milestone in our journey to bring this important treatment to patients and families worldwide, offering a new option with the potential to alter the course of lifelong PKU management. For more than 10 years, we have been committed to advancing the development of therapies for the PKU community, and we look forward to working with European regulatory authorities on the pegvaliase application.”

Recro Pharma

Based in Malvern, Pennsylvania, Recro has a PDUFA date of Saturday, May 26 for its New Drug Application (NDA) for intravenous meloxicam 30mg to manage moderate to severe pain. The IV formulation was designed using the NanoCrystal platform, which allows for enhanced bioavailability of poorly water-soluble drugs. NanoCrystal is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

Amgen

The FDA has assigned Amgen a PDUFA action date of Monday, May 28, which happens to be Memorial Day in the U.S., for its supplemental BLA (sBLA) for Prolia (denosumab) to treat patients with glucocorticoid-induced osteoporosis (GIOP). The sBLA was submitted on July 28, 2017, and utilized data from a Phase III clinical trial comparing Prolia to risedronate in patients receiving glucocorticoid treatment. Glucocorticoid drugs that are often used to treat inflammatory conditions have numerous side effects, including bone loss.      

“We believe that Prolia can address a critical treatment need for patients with glucocorticoid-induced osteoporosis, which is the most common drug-induced form of the disease,” said Sean Harper, Amgen’s executive vice president of research and development in an October 2017 statement. “We will continue to work closely with the FDA as they review our application and look forward to expanding Prolia’s benefits to patients with this serious condition that is often underestimated and untreated.”

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