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Europeans notch approvals for Vertex, Novartis drugs
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  • Publication:2012/7/31
The European Commission has opened the gates for another round of drug launches. Regulators gave their final blessing to Vertex Pharmaceuticals' ($VRTX) cystic fibrosis treatment Kalydeco, Almirall's lung drug Eklira Genuair, and Eisai's Fycompa seizure drug. And they granted Novartis ($NVS) dispensation to market its cancer drug Afinitor for breast cancer.
Kalydeco won approval for cystic fibrosis patients with a particular genetic mutation, which amounts to about 1,100 people in Europe, PM Live reports. It's the first drug to target the disease's underlying cause rather than mere symptom relief. It's also quite expensive--$294,000 is the U.S. price of a year's treatment--and Vertex says it's working with government authorities to get Kalydeco to patients. Analysts are looking for the drug to bring in $150 million worldwide this year and up to $982 million by 2015.
Meanwhile, Almirall got the final OK for its COPD inhaler, dubbed Eklira Genuair. The Spanish drugmaker developed the inhaler with Forest Laboratories, which recently won FDA approval under the brand name Tudorza Pressair. Almirall tapped Quintiles to help promote the drug in the U.K. And Eisai won the EU nod for Fycompa, to treat partial-onset seizures in epilepsy patients. It's the drug's first approval worldwide.
And last but not least, Novartis got the all-clear to market its kidney and pancreatic cancer drug Afinitor as a breast cancer treatment. The new approval--together with FDA's OK for the same indication 10 days ago--is expected to boost Afinitor sales considerably. Analysts now expect Afinitor to peak at around $2.2 billion.