Weekly Roundup 3.25.16

Well the first quarter of 2016 has sure blown by. We had the earliest Equinox since the 19th Century. Someone flipped a switch and everything started blooming at once. The cherry blossoms got well underway this week.

And here is what was blooming this week involving FDA – there were a cluster of new approvals, coincidentally – all monoclonal antibodies:

  • Anthrax Treatment Approved – First off, on Monday the agency announced the Friday approval (unusual timing) of a new treatment for inhalation anthrax. The treatment, Anthim, is a monoclonal antibody that neutralizes toxins from the anthrax and was approved under the “Animal Rule” which allows the consideration of testing on animals in lieu of humans where it is not feasible to do them in humans. The company press release can be found here.
  • New Plaque Psoriasis Drug Approved – Taltz, a monoclonal antibody, was approved this week by FDA for the treatment of moderate to severe psoriasis, FDA announced. Taltz acts to counter the effects of psoriasis, an autoimmune disorder, by binding to the protein that causes inflammation in psoriasis and thereby inhibits an inflammatory response. For a more in-depth discussion about the clinical trials leading to the approval, see the company press release here.
  • New Asthma Option Approved – People suffering from severe asthma despite treatment now have a new option with the approval announcement from FDA this week of Cinqair. The treatment is administered by a health care professional once every four weeks and works by reducing the amount of blood eosinophils, a white blood cell that contributes to the development of asthma. The company press release can be found here.

That’s all for me this week – I’m taking a little Spring Break. Have a good weekend everyone.

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