Regeneron's arthritis drug aces Phase III with the FDA in sight

Regeneron ($REGN) posted another round of clinical successes from its sweeping Phase III rheumatoid arthritis program, plotting to submit its Sanofi ($SNY)-partnered antibody for regulatory scrutiny this year.

Sarilumab, which works by halting the body's IL-6 receptors to tamp down inflammation, met its main goals in a 24-week Phase III study, significantly beating out placebo in reducing arthritis symptoms and improving physical function in patients who can't take TNF blockers like Humira. The antibody also hit the mark in separate Phase III studies designed to test its safety and vet the autoinjector device used to administer its subcutaneous doses, Regeneron said.

In the 546-patient efficacy trial, 60% of arthritis sufferers taking 200 mg of sarilumab every other week charted improvements of at least 20%, Regeneron said, and 56% of those getting 150 mg hit the same mark, beating out the 34% on placebo.

The latest victories cap a 6-trial Phase III effort for sarilumab, and Regeneron now plans to submit the antibody to the FDA in the fourth quarter of this year.

Sarilumab is yet another injection with blockbuster potential coming out of the wide-ranging partnership between Sanofi and Regeneron. The two are rolling toward an expected August approval for alirocumab, an antibody that lowers cholesterol by blocking a protein called PCSK9 and could bring in more than $1 billion a year at its peak, analysts say. Then there's dupilumab, an IL-4 and IL-13 antibody that has posted excellent results in eczema, asthma and a host of allergic diseases.

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