The US Food and Drug Administration (FDA) has recently granted Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi SA (NYSE:SNY) priority review status for the Biologics License Application (BLA) for dupilumab for the treatment of moderate-to-severe atopic dermatitis (AD) among adult patients. It has given the BLA a Prescription Drug User Fee Act (PDUFA) target action date of March 29.
The filing of the two companies include data from three Phase 3 clinical trials under the global LIBERTY AD development program that involvesd over 2,500 subjects suffering from inadequately controlled atopic dermatitis (AD). The development program primarily aims to evaluate the safety and efficacy of dupilumab as a monotherapy and in concomitant administration with topical corticosteroids.
The US FDA has already granted a Breakthrough Therapy designation to dupilumab for the said indication in 2014.
Clinical Trial Data
On Saturday, Regeneron Pharmaceuticals and Sanofi will present the latest data from two clinical trials evaluating dupilumab as a monotherapy for the said indication during an Investor Relations Thematic Conference Call at the 25th European Academy of Dermatology and Venereology (EADV) Congress. A question and answer (Q&A) portion will immediately follow the conference call.
It is important to note that the safety and efficacy profiles of dupilumab have not yet been fully established. Should it receive the necessary regulatory approvals, Regeneron and Sanofi Genzyme will share the commercialization rights for dupilumab for the treatment of moderate-to-severe AD.
Regeneron Pharmaceuticals opened at $410. It touched an intraday low of $401.10 before closing the session at $404.12. Regeneron Pharmaceuticals holds a 52-week high of $592.29 and a 52-week low of $329.09. The company has a market capitalization of $43.21 billion.
Meanwhile, Sanofi has begun the trading day at $38.11. The stock has reached a high of $38.15 and a low of $37.92 before closing at $38.04. Sanofi holds a 52-week high and a 52-week low of $51.88 and $37.41, respectively. It has a market capitalization of $99 billion.