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Sanofi’s rheumatoid arthritis biologic performs

pharmafile | May 22, 2015 | News story | Sales and Marketing Sanofi, rheumatoid arthritis, sarilumab 

French pharma giant Sanofi plans to submit its new rheumatoid arthritis biologic for regulatory approval in the US after it scored positive clinical trial results.

The Phase III study of the investigational treatment sarilumab, an injectable monoclonal antibody, found it improved rheumatoid arthritis (RA) symptoms after 24 weeks and improved patient’s physical function after 12 weeks.

The SARIL-RA-TARGET study included 546 RA patients who couldn’t take or who had not improved after taking TNF-alpha inhibitors. It tested the efficacy and safety of two sarilumab doses, added to non-biologic disease modifying anti-rheumatic drugs (DMARDs), compared to placebo and DMARDs.

After 24 weeks 61% of people who took the 200 milligram dose of sarilumab showed a significant improvement in their symptoms, while 56% of people in the 150 mg group and 34% in the placebo group improved. There was also a statistically significant improvement in physical function when compared to baseline after 12 weeks of treatment.

The most frequently reported adverse events included infections (30, 22 and 27% in the high, low and placebo groups respectively) and injection site reactions (8, 7 and 1 %), but Sanofi insist that “no unexpected safety findings were observed”.

The full results from the trial will be published at a medical congress later this year, and Sanofi says it plans to make a US regulatory submission planned for in quarter four of 2015.

Sanofi has also announced that two other studies in the same patient group have also met their primary endpoints: one in 217 patients that tested the sarilumab autoinjector device, and another in 202 patients looking at the safety of combining sarilumab and Roche’s RoActemra (tocilizumab) with DMARDs.

Sarilumab (REGN88/SAR153191) is being co-developed with Regeneron, who Sanofi is also partnering with to bring the biologic high cholesterol treatment Praluent (alirocumab).

Lilian Anekwe

 

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