Credit: Shutterstock photoPipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at timesomy. give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Earlier this week, Novartis AGNVS and Ligand Pharmaceuticals Incorporated LGND announced that the FDA has expanded Promacta's label to include the treatment of chronic immune thrombocytopenia (ITP) in children 1 year old and above, who have not sufficiently responded to corticosteroids, immunoglobulins or splenect.
The new label also includes an oral suspension formulation that has been especially designed for young children who cannot swallow tablets.
Promacta, initially approved in 2008 for adults, was approved for the treatment of children six years and older in Jun 2015.
As per information provided by the company, as many as 5 in 100,000 children are affected by ITP each year. Out of this, about 13-36% of children develop chronic versions of the disease.
Promacta is also approved in the U.S. for the treatment of low blood platelet counts in patients with chronic hepatitis C virus infection before and during treatment with interferon.
We remind investors that Promacta became a part of Novartis' portfolio earlier this year when the company acquired certain oncology assets from GlaxoSmithKline plc GSK . Promacta generated sales of $116 million in the second quarter of 2015 and is marketed as Revolade in ex-U.S. countries.
Novartis is currently looking to get Revolade approved in the EU for the treatment of adults with severe aplastic anemia who responded insufficiently to immunosuppressive therapy and are not eligible to receive a hematopoietic stem cell transplant. Last month, the company reported that the CHMP has adopted a positive opinion for this indication. The company is also seeking EU approval for the treatment of chronic ITP in children 1 year and older. A response should be out in the second half of 2015.
Other approved products for ITP treatment include Nplate.
Novartis carries a Zacks Rank #3 (Hold). Gilead Sciences Inc. GILD is a better-ranked stock in the health care sector sporting a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
