AstraZeneca PLC has sent a letter to British doctors advising that patients of Asian origin should be limited to 20 milligrams of its anti-cholesterol drug Crestor to reduce the risk of side effects.
The recommendation already exists for patients of Japanese and Chinese origin, and is being expanded, said AstraZeneca spokesman Steve Brown in London.
Studies show Crestor enters the bloodstream in higher concentrations in Asians than Caucasians.
U.S. prescribing guidelines mention the findings but do not explicitly recommend the lower dose. When the drug was approved by the FDA, AstraZeneca agreed to study the drug’s effects on Asians in the United States, said company spokeswoman Emily Denney in Fairfax. That study is ongoing, she said.
The drug is now available in up to a 40-mg dose in the United States.
Crestor is nearing approval in Japan at doses ranging from 2.5 mg to 20 mg. About 150,000 of the globe’s 15 million deaths from heart disease each year are in Japan, the company said.
Buoyed by tougher cholesterol-reduction guidelines and findings that it is the most potent anti-cholesterol drug at a given dose, AstraZeneca hopes to capture 20 percent of the statin market. But sales have been slower than expected because of competition and safety concerns.
In a report Wednesday, London equity firm Druganalyst suggested that AstraZeneca chief executive Tom McKillop had not been forthright with investors about prospects for its new drugs, including Crestor.