Regulatory Index News: 09/03/2018

Welcome to your Regulatory Index News update. Read here for stories on the FDA’s novel approval and expansion of scope as well as the EMA’s recall recommendation.

US approval for novel HIV treatment

The FDA have approved a new HIV therapy, Trogarzo, with the first novel mechanism of action in the area for 10 years. It is a humanised monoclonal antibody which blocks the HIV virus from infecting host cells by binding the CD4+ receptor’s extracellular domain 2, a site not used by other antiretrovirals. Trogarzo is administered intravenously once every 14 days and can be used in combination with other antiretrovirals. This approval is a particularly important approval for a small set of patients which develop resistances to multiple treatments. The approval was based on a phase 3 trial on 40 multidrug resistant HIV-1 patients which showed 82.5% of patients met the primary end point of a viral load reduction of at least 70% following a 7-day treatment period. Please click here if you would like to read more from a FiercePharma article.

Zinbryta suspension and recall recommended by EMA

The EMA have announced their recommendation for the immediate suspension and recall of Biogen’s Zinbryta, which was used to treat multiple sclerosis. The agency received 12 reports from patients taking the drug for serious inflammatory brain disorders, including encephalitis and meningoencephalitis, where 3 were fatal. The preliminary review indicated that these inflammatory brain disorders as well as other severe immune reaction could be causally linked to Zinbryta. Regardless of the judgement, as mentioned in Tuesday’s Regulatory Index News release, Biogen and AbbVie have already stated they will voluntarily withdraw the medicine from the market. If you would like to read further into this, please click here for a PharmaTimes article.

Bristol Myers Squibb’s Opdivo cleared for monthly dose

The FDA have cleared BMS’s Opdivo for a once every four-week dosing schedule and approved a shorter 30 minutes infusion time. These new updates leave patients and physicians greater choice with either a 240 mg dose every two weeks or 480 mg every four weeks for most indications. As several of the therapies have largely the same indications, this may be seen as a differentiating point for greater flexibility. And whilst this maybe a small update, it could provide another strong competitive advantage for BMS in the crowded immune-oncology space.  To read more on this story, please click here for an article from BioPharmaDIVE.



Max Lymbery

Date Published

09th March 2018

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