Well, it is really hot. Really really hot. And I am moving kind of slow, as one should probably do in the summer. I didn’t even get to the Weekly Roundup last week, which means that some of what I may cover this week, came from last, but was really interesting and so we are including it here. I am liable to be just as dull in August.
That said, there were some things of note:
- Advisory Committee Recommendations and the Psoriasis Landscape – Two different AdComms were held that were of note. In meetings of the Arthritis Drugs Advisory Committee on the 12th and 13th, it was recommended that two new biosimilars be recommended for approval for several indications held by the reference products. If these are both approved by FDA it would double the number of FDA approved biosimilars. Both applications sought approval of multiple indications, one of which included treatment for moderate to severe plaque psoriasis and both had unanimous approval of the committee. And in a related development, another biologic that sought approval for the treatment of moderate to severe plaque psoriasis received a recommendation of approval during a meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee on June 19, also with unanimous approval.
- Advisory Committee Calendar Light on NDA Deliberations – On a related note, right now the FDA calendar of upcoming advisory committee meetings has six scheduled during the balance of July through October, but only one of these is to consider a new product for market. As noted in a recent posting about FDA press releases, fewer approvals have been announced by FDA this year compared to last year’s banner year of approvals. Not every drug has an advisory committee hearing, but it nevertheless is one of the indicators about the approval rate moving forward. It could certainly change in the remainder of this year, but the limited and early indications are that this year may not meet the level of last year’s approvals.
- HIV Developments – The International AIDS Conference was held this week in Durban, South Africa. It is the second time the conference has been held there and the first time was not long after the introduction of anti-retroviral therapy (ART). At that time, the challenge was to get people treatment with ART as a means to save their lives – a goal that is still a work in progress. Since then the role of treatment as a prevention has emerged with important data published in the New England Journal of Medicine - Antiretroviral Therapy for the Prevention of HIV-1 Transmission. On a related note, NIH announced this week that it was expanding investment into basic medical research aimed at a cure for HIV.
Stay as cool as you can this weekend and take care.