Regulatory Index News: 30/11/2017

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OTC Viagra approved for UK sales

Following a public consultation, the UK MHRA has approved OTC switching of the once prescription only drug, Viagra, making it the first country globally to allow over-the-counter sales. This comes as a big win to Pfizer, which are working towards the OTC launch with their new brand, Viagra Connect, which should be available in UK pharmacies by Spring 2018. Pfizer are also launching an extensive education program for pharmacists to enable them to determine patient suitability for the treatment. This OTC switch will allow swifter and more readily available access to this treatment, whilst also in turn reducing costs of the NHS and diminishing the chance of counterfeit medicine purchase. If you would like to read more about this, please click here for a PharmaTimes article.

Eisai’s Halaven rejected for earlier use in breast cancer by NICE

NICE, the cost assessors of the UK, have rejected Eisai’s hope to extend Halaven’s usage to treat breast cancer patients whose cancer persists after a single round of chemo, rather than the previously approved use after two rounds of chemo. This decision came down to uncertain conclusions about the treatments survival data alongside the large cost of this drug. Whilst Halaven added, on average, 4.6 months of survival onto patients when compared with chemo alone, it did not show an increase of the time where the tumor doesn’t grow. It is now thought that Eisai will return with a discount offer to NICE as other companies have done so in the recent past. Please click here to read further from a FiercePharma article.

Catalyst’s rare disease drug is back for a 2018 US filing

Catalyst’s Firdapse, for rare autoimmune disease treatment of Lambert-Eaton myasthenic syndrome (LEMS), was refused authorization in the US almost two years ago after receiving a "refusal-to-file" letter from the FDA. The rare disease company is however back with positive topline data from a Phase 3 trial where Firdapse met both of its primary endpoints, leaving improved patient quantitative myasthenia gravis (QMG) scores and subject global impression (SGI). Catalyst are now hoping to use this data to support a New Drug Application to the FDA in the first quarter of 2018. If you would like to read more, please find a link here for an article from BioPharmaDIVE. 



Max Lymbery

Date Published

30th November 2017

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