Regulatory Index News: 23/03/2018

Welcome to your Regulatory Index News update. Three interesting developments with the FDA approving a new label expansion as well as a new biologic, where Novo present positive phase 2 data.

Seattle Genetics secures US label expansion for Adcetris

The FDA have approved Seattle Genetics’ Adcetris in combination with chemotherapy to treat adult patients with previously untreated stage 3 or 4 classical Hodgkin’s lymphoma, marking the first new treatment in this setting for over 40 years. The approval was based upon data from a phase 3 study (ECHELON-1) which showed that Adcetris and AVD (Adriamycin, vinblastine and dacarbazine) treatment led to statistically significant improvements in modified progression-free survival (PFS) when compared to the ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) control arm. The trial data has also supported the conversion of the drug’s accelerated approval to regular clearance to treat systemic anaplastic large cell lymphoma (sALCL) in adults after failure of at least one multi-agent chemotherapy. Please click here to read more from a PharmaTimes article.

FDA approval for Sun Pharma’s new psoriasis biologic

The US regulators have approved Sun Pharma’s Ilumya to treat adults with moderate to severe plaque psoriasis. The approval of the IL-23 binding inhibitor was based upon phase 3 data which showed significant clinical improvements for measurements of at least 75% of skin clearance (PASI 75) when comparing 100 mg Ilymya treatment with placebo. In the study (reSURFACE), 74% of patients achieved 75% skin clearance by week 28 after three doses, and 84% maintained 75% skin clearance at week 64 which greatly surpasses the 22% which maintained 75% skin clearance after re-randomisation to placebo. If you would like to read more, please click here for a PharmaTimes article.

Major weight loss data from Novo Nordisk's semaglutide phase 2 obesity study

Novo’s semaglutide, which has already shown it can aid in weight loss in diabetic patients, has now shown it can aid in weight loss for non-diabetic patients. The drug maker has released phase 2 data showing that subcutaneous injections of the drug helped patients lose up to 13.8% of their bodyweight after 52 weeks compared to just 2.3% for placebo. Semaglutide also seemed to aid most patients, with 83% losing at least 5% body weight and 65% losing at least 10% of their body weight. They now plan for a 68-week phase 3a trial to assess semaglutide in 4,500 patients as well as 12,500 patients for cardiovascular outcome studies. Please click here if you would like to read further from a FiercePharma article.

M L

Author

Max Lymbery

Date Published

23rd March 2018

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