Regeneron (REGN) and Sanofi informed that the FDA has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sarilumab. The drug is an investigational interleukin-6 receptor (IL-6R) antibody for adult patients with moderately to severely active rheumatoid arthritis (RA).
Nothing in the CRL contents insinuates that sarilumab is not safe, or not effective, or that the clinical trial data were not presented properly. All the letter stated is that there are certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished. This is one of the last steps in the manufacturing process.
Satisfactory resolution of these manufacturing-related deficiencies is required before the BLA can be approved. As a matter of fact, “Sanofi submitted a comprehensive corrective action plan to the FDA and is implementing the corrective actions specified in that plan. Sanofi is working closely with the FDA towards a timely resolution that addresses these concerns. The CRL does not identify any concerns relating to the safety or efficacy of sarilumab.”
That’s what the press release stated.
Prohost Observations and Comments
The drug in question, sarilumab is expected to be a blockbuster treatment for rheumatoid arthritis and, probably, for other inflammatory diseases, including autoimmune diseases. Results from Phase 3 monotherapy study demonstrate that the trial met its primary endpoint and that sarilumab was superior to adalimumab (marketed by AbbVie as HUMIRA®) in improving signs and symptoms in patients with active rheumatoid arthritis (RA) at Week 24.
The study, called SARIL-RA-MONARCH, also met important secondary endpoints including other measures assessing improvements in RA patients’ signs and symptoms and physical function.
Providing stronger efficacy than adalimumab monotherapy is encouraging. It is good news for Regeneron, Sanofi and for patients with rheumatoid arthritis. Adalimumab is one of the most commonly used biologic medicines in RA. Janet van Adelsberg, M.D., Senior Director, Clinical Sciences, Immunology and Inflammation, Regeneron said, “This is the first time an IL-6 receptor blocker delivered subcutaneously (under the skin) has demonstrated superiority over adalimumab monotherapy in RA.”
Adalimumab is a best seller and generated billions of dollars in revenues for AbbVie. As a matter of fact, the drug is Abbvie’s most selling product.
So, causing a sell-off of REGN does not make sense. Investors who are selling the firm’s stock based on the FDA CRL might believe that the complete response letter is kind of condemnation of the drug in question, which is not the case with Regeneron’s and Sonofi’s drug sarilumab. This time, the FDA’s complete response letter (CRL) will have no negative impact on the drug’s approval and marketing.
Sanofi and Regeneron remain committed to providing the therapy to RA patients in the U.S. as quickly as possible.
If FDA approved, sarilumab would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.
Regeneron is a solid biopharmaceutical Company with a future as promising as that of other fast growing firms such as Incyte, Seattle Genetics and other top-tier firms.
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