- Approval of Multiple Myeloma Treatment – In one of the rather rare examples of FDA not following a recommendation of one of its advisory panels, FDA this week announced approval of the first histone deacetylases (HDACs) inhibitor, Farydak, for the treatment of multiple myeloma. The treatment is being indicated for patients who have received at least two prior standard therapies, including bortezomib and an immunomodulator agent. It is to be used in combination with bortezomib and dexamethasone. FDA notes in its press release that while the advisory committee did not offer a recommendation for approval that the company submitted post-meeting information for a different indication. Clinical studies showed that study subjects receiving the treatment experienced a delay in disease progression. There will be a boxed warning for the label. This was another priority review by FDA with orphan designation and was considered under the accelerated approval program allowing for access during confirmatory clinical trials. The company’s multimedia news release can be found here.
- FDA Approves Antibacterial – The agency announced approval of antibacterial Avycaz (ceftazidime-avibactam) to treat adults with complicated intra-abdominal infections in combination with metronidazole. Also approved for complicated urinary tract infections, including kidney infections where there is limited or no alternative treatment opions. The product is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, a new beta-lactamase inhibitor. This was a priority review for FDA and had Qaulified Infections Disease Product (QDIP) designation which confers an added 5-year exclusivity period. The company release can be found here.
- AdComm for Second Biosimilar Postponed – Two weeks ago the Weekly Roundup reported that an Arthritis Drugs Advisory Committee meeting had been scheduled – the second to consider a biosimilar. The product is a biosimilar for the reference product Remicade® (infliximab). However, the date which was set for March 17 was changed to date to be specified at another time. The agency said that the delay was due to pending information requests with the sponsor of the application.
That’s it for me this week folks. Have a good weekend!