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Novartis’ Revolade Approved for Pediatric Patients in the EU – Yahoo News
Pharma News

Novartis NVS announced that the European Commission (EC) has approved Revolade for the treatment of pediatric patients (aged 1 year and above) suffering from chronic immune (idiopathic) thrombocytopenic purpura (ITP) who are refractory to other treatments such as corticosteroids and immunoglobulins.

Revolade is approved in both a tablet formulation as well as an oral suspension formulation which makes it easier to swallow for children who cannot swallow tablets.

As per the U.S. National Institutes of Health, ITP is a rare blood disorder that affects about five in 100,000 children every year, while chronic ITP affects 13–36% of those suffering from ITP.

We note that Revolade is already approved in Europe for the treatment of adults. The drug is marketed under the brand name Promacta in the U.S under a collaboration agreement with Ligand Pharmaceuticals, Inc. LGND. In Aug 2015, the FDA approved an oral suspension formulation of Promacta for younger children with chronic ITP who may not be able to swallow tablets.

Promacta is also approved for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy, and for the treatment of patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy.

Sales of Revolade came in at $402 million in 2015. A label expansion of the drug will further boost its sales.

Approval of new drugs and label expansion of existing ones should bode well for Novartis as it has been facing stiff generic competition for some of its key drugs like Diovan of late. Additionally, its oncology drugs are facing competition in the form of immuno-oncology therapies.

Moreover, its Alcon segment is facing a decline in surgical equipment sales in the U.S. and emerging markets, while Ophthalmic Pharmaceuticals is grappling with issues like the threat of increased generic competition in the U.S.

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