Regulatory Index News: 20/04/2018

Welcome to your Regulatory Index News digest today. Read here for the recent developments in the industry including two new US approvals and an interesting phase 3 trial.

Rigel secures FDA approval and prepares for May launch

The FDA have given Rigel their first ever approval for the drug, Tavalisse, which has also received an Orphan Drug Designation allowing a longer market exclusivity period. The drug is an oral spleen tyrosine kinase inhibitor and will be used to treat autoimmune attacks in chronic immune thrombocytopenia (ITP) which is characterised by excessive bruising, bleeding and fatigue. With an estimated 65,000 US adults with ITP, and an estimated 50% of those not actively bring treated for their disease, there is a huge growth potential for this medicine which has few rivals. If you would like to read further on this story, please click here for a BioPharmaDIVE article.

US approval for BMS’ Opdivo/Yervoy combo in first-line kidney cancer

Bristol Myers Squibb have been awarded their US approval for a combination of its immunotherapy drugs, Opdivo and Yervoy, to treat advanced renal cell carcinoma (RCC) in the first-line setting. The approval was based on Phase 3 (CheckMate-214) data which showed the combination significantly increased overall survival by 37% compared to the current standard of care, Pfizer’s sunitinib. This is brilliant news for those diagnosed with advanced RCC, where currently just 36% of those survive beyond one year and just 8% live beyond five years. On top of this development, BMS have also released new findings that the Opdivo/Yervoy combination significantly reduces the risk of progression or death by 42% against chemotherapy in first-line advanced non-small cell lung cancer (NSCLC) with high tumour mutation burden. Please click here to read more from a PharmaTimes article.

Merck starts head-to-head phase 3 trial of their vaccine against Prevnar 13

Merck are targeting the pneumococcal market as they pit their conjugate vaccine, V114, which is designed to protect against 15 serotypes of pneumococcal disease against Prevnar 13 in a head-to-head phase 3 trial. In this trial of 600 participants, Merck are to test V114 against the Pfizer shot before administering their Pneumovax 23 one year after their initial immunisations. They are also running a second phase 3 trial where they will test their vaccine in 300 adults with HIV, to then administer Pneumovax 23 eight weeks later. If you would like to read more, please click here for an article from FiercePharma.



Max Lymbery

Date Published

20th April 2018

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