Vertex Pharmaceuticals Incorporated (VRTX) received good news when the FDA approved its supplemental new drug application for its cystic fibrosis (CF) drug Kalydeco.
Kalydeco has now been approved for use in patients suffering from CF aged six years and above with an R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
The approval was already on the cards with the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommendation of the same in Oct 2014.
With this approval, Kalydeco can now be used in the U.S. in CF patients aged six years and older with one of these ten mutations: R117H, G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P or G1349D.
Our Take
The company has witnessed encouraging Kalydeco sales since its launch, with the drug generating sales of $339.4 million in the first nine months of 2014. Its label expansion will further boost sales and strengthen Vertex Pharma's position in the CF market. Following the latest approval, the drug can be used for treating more than 3,100 people aged six years and above in North America, Europe and Australia with specific mutations of the CFTR gene.
Moreover, Vertex Pharma submitted a Marketing Authorisation Application variation to the European Medicines Agency for the approval of the drug in the same indication in Jul 2014.
Meanwhile, we are encouraged by Vertex Pharma’s progress on its CF pipeline. Vertex Pharma has also filed for Kalydeco in combination with lumacaftor for use in CF patients (≥12 years of age) who have two copies of the F508del mutation in the CFTR gene.
Vertex Pharma is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Biogen Idec (BIIB), The Medicines Company (MDCO) and Regado Biosciences, Inc. (RGDO). While The Medicines Company and Regado carry a Zacks Rank #1 (Strong Buy), Biogen holds a Zacks Rank #2 (Buy).
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