For the past 7 years Merck ($MRK) has maintained a star rating by its program for Bridion (sugammadex), remaining convinced of its big market potential and staying upbeat after three consecutive rejections at the hands of the FDA. But regulators finally relented today, giving the pharma giant a green light on its fourth try for the drug, which is used to reverse the effects of adult anesthetics.
Bridion is now OK'd for use to reverse the effects of neuromuscular blockade triggered by rocuronium bromide and vecuronium bromide, neuromuscular blocking drugs used to freeze vocal cords and muscles during surgery.
"Bridion provides a new treatment option that may help patients recover sooner from medications used for intubation or ventilation during surgery," said Dr. Sharon Hertz, 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 drug has been plagued by questions about potential side effects that stretches back to when Schering-Plough was developing the drug. Regulators have fretted about infrequent instances of anaphylaxis, a severe and potentially lethal allergic reaction. Doctors were also warned to monitor for a slowing heart action that could spur cardiac arrest. Those safety concerns spurred demands for new studies as well as regular regulatory delays.
The long, lingering uncertainty over sugammadex helped create a crisis atmosphere at Merck a couple of years ago. The inability of Merck to successfully land major new approvals led to a switch at the top in R&D, with Roger Perlmutter coming in to execute a major revamp and cut costs. Since then Merck has enjoyed a big win with the approval of the landmark checkpoint inhibitor Keytruda. But just this morning the pharma giant was hit with a fresh setback after FDA experts shot down its move to gain approvals to use Vytorin and Zetia for preventing heart attacks and stroke.
Bridion is already in use in dozens of countries around the world, and some analysts believe that a U.S. approval could pump up peak sales past the $700 million mark. Others aren't so ambitious.
"We estimate that there are approximately 30M general surgeries performed in the US where neostigimine is applicable, with approximately 5M units being used each year," notes Barclays' Geoff Meacham. "Given its likely premium pricing, we assume Bridion will primarily be used for rescue situations with some limited use in general NMB reversal. We model $20M in 2016 US sales vs. consensus of $47M, but see higher peak sales of $275M in 2020 compared to the Street's $210M. "
- here's the release