Bristol-Myers Squibb and partner Japan's Otsuka Pharmaceutical Co say that US health regulators have granted a priority review of their schizophrenia drug Abilify for the treatment of paediatric patients aged 13 to 17.
The antipsychotic is already approved to treat adults with schizophrenia or acute manic and mixed episodes associated with bipolar disorder and getting priority review status means that the US Food and Drug Administration will make its decision on whether to approve the additional use of Abilify (aripiprazole) by teenagers within six months, rather than the usual 10- to 12-month review period.
The supplemental New Drug Application is based on data from a six-week, double-blind, randomised, placebo-controlled study, evaluating the use of Abilify in 302 “ethnically diverse” paediatric patients and was conducted at 101 centres in 13 countries. If the drug has a successful review, that will do no harm to B-MS’s finances and Abilify, which had first-quarter sales of $366 million, up 29%, has become an extremely important drug for the firm, especially since the blip in revenues suffered by the clotbuster Plavix (clopidogrel) and generic competition cholesterol-lowerer Pravachol (pravastatin).
Plavix use extended in Canada
Speaking of Plavix, B-MS and Sanofi-Aventis noted that Health Canada has expanded approval for the use of the blood-thinner in combination with aspirin to reduce the risk of heart attack, stroke or death in patients with all acute coronary syndromes. The approval is an expanded indication for Plavix, which offers protection from all types of heart attacks.
"This new indication is an important advance in the treatment of ACS for patients with STEMI (ST-segment elevation myocardial infarction) as myocardial infarction is a life-threatening condition," said Shamir Mehta, director of interventional cardiology at McMaster University and Hamilton Health Sciences.