UPDATE (27/06/2017): The EMA has followed suit by approving Kevzara for moderate to severe rheumatoid arthritis.
UPDATE (23/05/2017): More than six months after the FDA turned back Sanofi’s and Regeneron’s new rheumatoid arthritis (RA) drug based on manufacturing issues, the agency now handed out its final approval for the anticipated blockbuster drug. Entering the crowded RA market, the drug will have a list price of $39,000 (€34,650) per year, which is 30% lower than the two most widely used TNF-alpha drugs, Humira and Enbrel. This could give the new IL-6 inhibitor, which is expected to rake in $1.8B (1.66€) by 2020, a competitive advantage on the market.
Original Publication 24/04/2017
Sanofi and Regeneron have just received CHMP Positive Opinion for their blockbuster drug for rheumatoid arthritis, which outperforms the top-seller Humira.
Sanofi and Regeneron recently suffered a setback for their much anticipated new IL-6 inhibitor, sarilumab, when the FDA issued a complete response letter related to “manufacturing deficiencies” at a Sanofi fill-finish facility, delaying its potential US approval. Now, the Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the marketing authorization of Kevzara (sarilumab) and recommends its approval for use in adult patients with moderately to severely active rheumatoid arthritis (RA).
The European Commission is now set to make its final decision in the coming months, but things are looking good for the two pharma players. The CHMP opinion was based on seven Phase III trials including data from more than 3,300 RA patients, and after the new biological recently outperformed AbbVie’s top-selling Humira in a Phase III head-to-head study in rheumatoid arthritis, the drug candidate has been projected to reach 2020 sales of $1.8B (1.66€) upon FDA approval.
Sarilumab is a monoclonal antibody directed at the IL-6 receptor and inhibits signaling of this inflammatory cytokine, which is thought to play an important role in the development of auto-inflammatory processes. The new drug candidate seems to be a serious competition to AbbVie’s number one RA drug Humira, which generated around $16B in sales last year.
Sarilumab’s approval in the EU would mean the second huge drug approval of the year for the Regeneron/Sanofi combo. Last month, the two companies already scored FDA approval for dupilumab, a new breakthrough antibody for the treatment of atopic dermatitis, which is projected to rake in €2.8B ($3B) in sales.
Since the companies had to watch their cholesterol drug Praluent fail in court following a patent infringement suit from Amgen in January, the two pharma giants have been facing a positive turn of events. However, sarilumab will still be facing competition on the RA market. Roche’s tocilizumab is another IL-6 blocker, which is already marketed for the treatment of RA, and compared to Humira, sarilumab was not able to outperform this antibody in clinical studies.
Images via shutterstock.com / Chaowalit Seeneha and Designua