Gilead Sciences, Inc. GILD announced that the FDA has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, an experimental treatment for moderately to severely active rheumatoid arthritis (RA), which it is developing with Galapagos GLPG.
The agency has now requested data from the MANTA and MANTA-RAy studies before completing its review of the NDA. These studies are designed to assess if filgotinib has an impact on sperm parameters. Additionally, the FDA has some concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose.
Both studies are fully recruited and top-line results are expected in the first half of 2021.
The news of the CRL was disappointing as it will result in a delay in approval of the candidate.
We remind investors that filgotinib is currently under review by regulatory authorities around the world. The European Medicines Agency’s Committee for Medicinal Products for Human Use recently gave a positive opinion on the candidate, recommending marketing authorization for filgotinib in the EU for the treatment of adults with moderate to severe RA who have responded inadequately or are intolerant to one or more disease-modifying anti-rheumatic drugs.
We note that Gilead and Galapagos have collaborated for the development and commercialization of filgotinib in rheumatoid arthritis and other inflammatory indications. The companies have multiple clinical study programs for filgotinib in inflammatory diseases, including the FINCH phase III program in RA, the phase III SELECTION trial in ulcerative colitis, the DIVERSITY phase III study in Crohn’s disease, the phase III PENGUIN studies in psoriatic arthritis, and phase II studies for uveitis, small bowel and fistulizing Crohn’s disease.
Gilead’s shares have gained 6.2% in the year so far compared with the industry’s growth of 3.9%.
The company has been in the news since the onset of the year as it leads the race for a possible treatment of the coronavirus disease. It submitted a New Drug Application (NDA) for Veklury (remdesivir) to the FDA. The drug is an investigational antiviral for the treatment of patients with COVID-19. Veklury is currently available in the United States under an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is running a race against time to come up with treatments and vaccines to cure the contagion.
Roche RHHBY initiated a late-stage study on its arthritis drug, Actemra/RoActemra, in combination with remdesivir in hospitalized patients with severe COVID-19 pneumonia. Alexion ALXN is also evaluating its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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