Regeneron Pharmaceuticals, Inc. (REGN) Announced Kevzara Approval by the European Commission


Corporate News Blog – Regeneron and Sanofi Announced Kevzara Approval by the European Commission

At Pro-TD, we make it our mission to bring you news that matter about the stock you follow. Today, our research desk covers a blog story on REGN and SNY. Go directly to your stock of interest and access today’s free coverage at:

Rheumatoid Arthritis

RA is a difficult-to-treat, lifelong disease, where many healthcare providers are challenged with finding a treatment that works for their patients. RA affects about 2.9 million people in Europe itself, where in the immune system it attacks the tissues of the joints, causing inflammation, joint pain, swelling, stiffness, fatigue and eventually joint damage and disability, and is most common in those aged between 35 to 50 years old.

Kevzara is indicated for the treatment of adult patients with moderately to severely active RA, who have had an inadequate response to one or more DMARDs. Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) and blocks pro-inflammatory IL-6 mediated signaling. Patients with RA usually have elevated levels of IL-6 in their synovial fluid, where both pathologic inflammation and joint destruction are hallmarks of RA. Kevzara was developed using the Company’s proprietary VelocImmune technology that yields optimized full-human antibodies.

The EC Approval

The EC Approval based on a positive opinion by European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), evaluated results from seven Phase-3 trials, in the global SARIL-RA clinical development program. The studies incorporate data from about 3,300 adults with moderately to severely active RA, who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs.

In the Phase-3 MONARCH study, Kevzara 200 mg was indicated against adalimumab 40mg (also known as HUMIRA by AbbVie) monotherapy, where the former was observed in reducing disease activity and improving physical function, with more patients achieving clinical remission over 24 weeks. In Phase-study with Kevzara plus MTX, reduced signs and symptoms of RA were observed, with improved physical function. At week 52, it inhibited the progression of structural damage by 91% for the Kevzara 200 mg dose and 68% for Kevzara 150 mg dose, compared to placebo plus MTX.

The Delayed FDA Approval

Last year, in October 2016, Sanofi and Regeneron expected that at the end of the month, i.e., the PDUFA date, the Companies would get the US nod for its IL-6R contender in RA. However, the Companies were hit by a complete response letter from the FDA for manufacturing concerns, where experimental med sarilumab faced months of delay. According to the Companies, FDA disapproved the med over certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait Facility. However, on May 22, 2017, after almost 7 months of delay, the Companies received FDA approval for sarilumab, paving the path for future development and eligibility for manufacturing and sales of sarilumab in the US.

Last Close Stock Review

At the closing bell, on Wednesday, June 28, 2017, Regeneron Pharma’s stock climbed 2.20%, ending the trading session at $513.19. A total volume of 932.79 thousand shares have exchanged hands. The Company’s stock price skyrocketed 30.20% in the last three months, 32.97% in the past six months, and 51.04% in the previous twelve months. Moreover, the stock soared 39.80% since the start of the year. The stock is trading at a PE ratio of 61.74 and currently has a market cap of $54.08 billion.


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