The CHMP also gave positive opinions to applications for the extension of indication in seven brands.
Lilly's Adcirca (tadalafil), currently marketed as erectile dysfunction drug Cialis, is set to become a pulmonary arterial hypertension treatment.
The Medicines Company UK's Angiox (bivalirudin) was recommended to include patients with ST-segment myocardial infarction undergoing primary percutaneous coronary intervention.
It is currently authorised for treatment of adult patients with acute coronary syndromes planned for urgent or early surgical intervention.
Eli Lilly's Cymbalta and Boehringer Ingelheim's Xeristar (both duloxetine) should both have their indications extended to include treatment of major depressive disorder.
Finally, the indications of three hypertension drugs - Boehringer Ingelheim's Micardis and Bayer Schering's Pritor and Kinzalmono (all telmisartan) - are set to be extended.
They will now include the reduction of cardiovascular morbidity in patients with manifest atherothrombotic cardiovascular disease or type II diabetes mellitus with documented target organ damage.
Source:http://www.inpharm.com/news/european-regulators-begin-tysabri-review
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