It seems 2015 is moving even faster than 2014 as we prepare for the last week of January even though it feels as if the holidays were only last week. It has been that time of year for reflection, looking back at what we’ve done and forward to what needs to be done. And looking forward as well to Daylight Savings which is March 8 this year. Counting the moments….
In the meantime, a bit of reflection on some events of this week:
- New Psoriasis Drug Approved - FDA announced approval of a new biologic treatment for adult patients with moderate to severe plaque psoriasis. Cosentyx (TM) (secukinumab) is first approved monoclonal antibody that binds to Interleukin IL-17A. The approval follows a unanimous recommendation for approval from an October 2014 meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee. The manufacturer – Novartis – issued a dynamic multimedia release that included not one, but two infographics, among other things.
- FDA Clarity on Wearables - In 2011 the agency had issued a draft guidance with respect to medical apps and a final guidance in 2013. In that guidance, FDA stated that it was aiming for functionality and not platform in its approach to regulating apps. In that guidance, the agency said that many mobile apps aimed at health were not devices and would not be regulated and many might be devices, but would not be regulated because they were low risk. The guidance aimed regulation at those apps which were devices and could pose risk if they failed and termed these regulated devices as mobile medical apps. This week FDA issued a draft guidance on the policy for low risk devices (wearables) which expresses it a bit differently but the effect is the same – FDA is not looking to regulate general wellness products and present low risk. The agency outlines the parameters in the draft guidance very clearly and provides not only examples, but a decision-tree as well in the draft entitled “General Wellness: Policy for Low Risk Devices”.
- AdComm Recommends Antibiotic Approval – The Anti-Infective Drugs Advisory Committee met this week to consider an Astellas application for a new antibiotic isavuconazonium for two indications. On the first indication – for the treatment of invasive aspergillosis the committee voted unanimously to recommend while for the indication for the treatment of invasive mucormycosis (also known as zygomycosis) the committe voted to recommend approval with 8 in favor, 2 against and 1 abstention. According to the press release from the company, the PDUFA date is March 8, 2015. You can look for the transcript of the meeting to appear usually within 3 weeks.
That’s it for me this week folks. Have a good and safe weekend.