Regulatory Index News: 14/12/2017

Welcome to your Regulatory News update. A couple of big US approvals and the troubling circumstances in Philippines leaves plenty to read about today.

FDA approval for Sanofi's Humalog follow-on

Sanofi have been awarded an approval for their diabetes follow-on treatment to Eli Lilly’s insulin Humalog, which is to be marketed as Admelog​. The approval went through an abbreviated pathway which allows the biologic under review to draw on safety and efficacy information from a previously approved and highly similar product. Whilst pricing has not yet been released, it is expected before the treatment launches in early 2018. This comes at a good time for Sanofi where it may offset their 10% yearly declining diabetes sales and help in the increasingly crowded diabetes space with pricing pressures. If you would like to read more on this story, please click here to read an article from BioPharmaDIVE.

GSK’s asthma biologic gains FDA approval for rare autoimmune disease

Nucala, previously approved for severe eosinophilic asthma, has become the first ever US approved therapy to treat a rare disease known as eosinophilic granulomatosis with polyangiitis (EPGA) or Churg-Strauss syndrome. This autoimmune disease causes vasculitis, which is the inflammation of the blood vessel walls, and is characterised by asthma, high eosinophil levels, and inflammation of small- to medium-sized blood vessels affecting various organ systems in the body. The treatment is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) which is formed using DNA recombination in Chinese hamster ovary cells. The approval was based upon a Phase III MIRRA trial where results conferred a significantly greater accrued time in remission compared with placebo. Please click here if you would like to read further from a PharmaTimes article.

Sanofi official defends Dengvaxia safety in Philippines whilst further questions accumulate

A Sanofi official has testified the safety of their Dengue vaccine to Philippines' lawmakers in hope that they look past the mounting safety issues and provide the vaccine to their population. The executive emphasized that the vaccine has not been recalled in any of the other 11 countries for which they market, indicating that the product is indeed safe. Alongside this, there has been scrutiny that the immunization campaign went ahead through the department of health whilst expert advice suggested a more measured approach due to the unproven vaccine safety and efficacy. This has been deemed a “reckless disregard of processes” by the senator leading the investigation stating that the program went ahead with “undue haste”. Please click here to read more from a FiercePharma article. 

M L

Author

Max Lymbery

Date Published

14th December 2017

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