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Amgen Gets Positive CHMP Opinion to Expand Nplate’s Label


Amgen, Inc. AMGN announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion to expand the label of Nplate to include the pediatric population.

Nplate is presently marketed for the treatment of chronic immune thrombocytopenic purpura (ITP) – an autoimmune disease characterized by low platelet count – in adults. Amgen is looking to get Nplate approved for use in pediatric patients (one year of age and older) who are refractory to other treatments like corticosteroids and immunoglobulin.

The positive opinion was based on five studies demonstrating that Nplate reduces the rates of bleeding in children with this rare blood disorder.

Amgen’s shares have rallied 17.8% this year so far, better than the industry’s growth of 2.3%.

In a separate press release, Amgen and partner Allergan AGN announced that the CHMP has rendered a positive opinion for the marketing application of its biosimilar version of Roche’s RHHBY cancer drug Avastin, ABP 215. According to the companies, this may be the first bevacizumab biosimilar, which has been recommended for approval in the EU

The Avastin biosimlar was approved in the United States in September and will be marketed by the trade name of Mvasi.

We remind investors that Amgen and Allergan have collaborated for the worldwide development and commercialization of four oncology antibody biosimilar medicines including Roche’s Avastin, Herceptin and Ritixan.

In fact, Amgen has 10 biosimilars in its pipeline. Its biosimilar version of Abbvie’s ABBV rheumatoid arthritis drug Humira, Amjevita, was approved by the FDA last year and in the EU in March this year for the same indications. However, per a settlement with AbbVie, Amgen will begin selling Amjevita in most countries in the EU next year and in the United States from January 2023

Currently, Amgen has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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