The news boosted Glaxo's shares - down 12p at one point - 26p to 774p. The drug, known as Imitrex in the US but Imigran elsewhere, is one of three potential blockbusters Glaxo hopes will take over from Zantac, its best-selling ulcer treatment, which loses its patents from the mid-1990s.
The Food and Drug Administration, the US regulator, gave preliminary approval earlier this month, but the wording of packaging and prescription information had to be agreed before formal clearance was given. Glaxo is still awaiting the go-ahead for the oral formulation, submitted for approval a year after the injections.
The US was the last big market to be approved. The treatment is already available in 22 countries, including Britain, France and Germany. Sales in the year to June 1992 were pounds 43m, but analysts believe it could achieve worldwide sales of more than pounds 1bn by 1996 compared with pounds 2bn-plus estimated for Zantac in the same year. Many migraine sufferers do not consult their doctor, so the success of Imigran will partly depend on Glaxo's ability to educate them about the benefits.
A spokesman for Glaxo said the price would not be revealed until the launch date, but the decision is likely to be politically sensitive. Drug companies have been criticised for excessive profits and Bill Clinton, the US president-elect, has said he will cut the country's medical bill. Merck, the US drugs giant, has set an unusually low price for its prostate cancer treatment, Proscar.
In Europe, where Imigran's pricing has also been under attack, the group is trying to set a uniform price across all countries to prevent parallel imports.Reuse content