Novartis, Amgen, AstraZeneca Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Novartis, Amgen, and AstraZeneca.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday May 16, 2018 date to Tuesday May 22, 2018.

FDA OKs Novartis’, Amgen’s Potential Blockbuster Migraine Drug Aimovig
The US Food and Drug Administration (FDA) has approved Novartis’ and Amgen’s Aimovig (erenumab), a drug used to prevent migraines in adults by blocking the calcitonin gene-related peptide receptor. Novartis identifies Aimovig as a potential blockbuster drug.

Aimovig is expected to reach blockbuster status in 2022 with sales of $1.170 billion, according to a recent analysis by Clarivate Analytics.

The European Medicines Agency marketing authorization application for Aimovig is under review. Novartis says it expects approval in the European Union in the coming months.

Aimovig is one of 10 expected blockbuster launches Novartis expects in the coming years. At a recent investors’ meeting, Novartis Chief Executive Officer Vas Narasimhan highlighted the company’s growth strategy, which includes 10 potential blockbuster launches in the next three years, further investment in gene therapy and oncology products, an increased focus on digital technologies, and improving profitability for Sandoz, its generics arm.

Source: Novartis and Amgen


FDA OKs AstraZeneca’s Hyperkalemia Drug Lokelma 
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) for treating adults with hyperkalemia, a condition of elevated potassium levels in the blood associated with cardiovascular, renal, and metabolic diseases.

Lokelma is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, which acts as a potassium-removing agent.

The European Commission granted marketing authorization for Lokelma in the European Union on March 22, 2018.

Source: AstraZeneca

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