Poor GSK. Their migraine drug sumatriptan (Imitrex in the US, Imigran in the UK) is nearing the end of its patent.
So, evergreening and OTC strategies come to the fore.
In the UK GSK have successfully gone for the OTC option; enter Imigran Recovery.
In the US they chose to develop a combo drug. This has, alas, not been so successful. The U.S. regulators have said they will not approve the combo drug developed by Pozen Inc. and GSK until new safety information is available, the drugmakers said on Friday, sending Pozen shares down 50 percent.
The request by the U.S. Food and Drug Administration for additional safety information on the drug, Trexima (Imitrex + naproxen), could require new studies, the companies said.
New studies, if required, could delay the drug for years. GSK , which has been counting on Trexima as a replacement for its older migraine drug Imitrex, had been expecting to launch the new drug in the third quarter of this year.
The companies said in a joint release that the FDA decided the drug Trexima is effective, and issued an "approvable letter," or conditional approval, for the drug on that basis.
"The agency has requested additional safety information on Trexima, which may require new studies," the companies said in a release.
The companies said they hope to meet with the FDA as soon as possible to discuss the approvable letter and determine possible steps to gain full approval.
So, score one for GSK UK. That is unless OTC Imitrex is on the way.....
2 comments:
Bet that gives them a bit of a headache.
Having paid dearly for over 10 years for Imitrex it is time for generic. I don't even care if it's over the counter just want it to be cheaper!
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