Tuesday, December 15, 2015

Over Seven Years Later, Full FDA Approves Sugammadex -- S-P/Merck's Bridion® -- In The US

I will open the post by saying Merck deserved this win. The Merckies' regulatory affairs team earned it -- by repairing what the S-P people had. . . damaged. It took over seven years, but they got it done. It seems (based on my eight years of close observations) that it was much more the legacy Schering-Plough people -- marketeers, along with Carrie S. Cox, and then-CEO Fred Hassan, mostly -- who ended up ham-stringing this drug candidate before the regulatory agency, in the US. They simply puffed w-a-a-a-y too much, and tried too hard to sugar coat the issues raised by several legitimate independent scientific reviews.

So, in my view, the tale of sugammadex will go down as a cautionary one, from the perspective of would be marketeers, vis a vis the United States Food and Drug Administration. A tale of what happens when one oversells one's wares, rather egregiously. [Sugammadex may yet end up with a less than free wheeling label, due to the legacy S-P over-hyping.] But I digress -- this is a very good day for Merck's regulatory affairs team.

To be branded here -- as it is in Europe -- as Bridion®, the drug is unlikely to ever be independently material to Merck's revenue (Merck is just too big). It will be a nice, if smallish, franchise though, for Kenilworth. From the just released FDA announcement (three days ahead of schedule -- it was due by December 19, 2015), then:

. . . .The U.S. Food and Drug Administration today approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.

Rocuronium bromide and vecuronium bromide are neuromuscular blocking drugs that cause temporary paralysis by interfering with the transmission of nerve impulses to the muscle and are used to paralyze the vocal cords when patients require an artificial airway or breathing tube for surgery, a process called tracheal intubation. They can also be used to prevent patients from moving during surgery while they are receiving general anesthesia. Neuromuscular blocking drugs are also sometimes used to prevent the body from breathing automatically when a patient has to be placed on a ventilator.

"Bridion provides a new treatment option that may help patients recover sooner from medications used for intubation or ventilation during surgery," said Sharon Hertz, M.D., director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research. "This drug enables medical personnel to reverse the effects of neuromuscular blocking drugs and restore spontaneous breathing after surgery."

The safety and efficacy of Bridion were evaluated in three Phase 3 clinical trials involving 456 participants. The return to recovery time was faster overall for the Bridion treatment groups compared to the comparator groups, with most participants recovering within 5 minutes of routine use of Bridion.

Due to concerns about the nature and frequency of anaphylaxis (severe, potentially life-threatening allergic reaction) and hypersensitivity reactions reported in the clinical trials, Bridion was further evaluated in a randomized, double-blind, parallel-group, repeat-dose trial. Of the 299 participants treated with Bridion, one person had an anaphylactic reaction. Clinicians should be aware of the possibility of a hypersensitivity reaction or anaphylaxis and should intervene as appropriate. . . .

The cynical voice within me wonders whether the full Commission is impliedly sending a signal here -- that it might vote the label expansion for Vytorin next month, despite the no vote from its own Advisory Committee, yesterday. But maybe it is just the FDA moving at its own pace. We shall see. Onward, and smiling ear to ear, as I like. . . to take my time -- as well. . . . if it is worth doing, it is worth doing, thoroughly.

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