Teva’s Fremanezumab Gets September Action Date from FDA



Latest update on Teva’s migraine drug

On May 23, 2018, Teva (TEVA) announced that the FDA’s Prescription Drug User Fee Act action date is set for September 16, 2018, for its migraine drug Fremanezumab. Also, the company stated that there are no additional data requirements from the FDA, and it’s likely to launch the drug by mid-September.

According to Brendan O’Grady, head of Teva’s North America Commercial division, “We are preparing to launch the product immediately when approved. Migraine patients have waited years for new preventive treatments to enter the market.”

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Fremanezumab is a key growth driver for Teva

Fremanezumab is an investigational therapy for the preventive treatment of migraines. Teva’s anti-CGRP (calcitonin gene-related peptide) monoclonal antibody is under review for administration in the form of injectables for quarterly and monthly dosages. The drug is also being reviewed in Europe and is going through the standard procedures and timelines. Fremanezumab is expected to be one of Teva’s major growth drivers going forward.

During Teva’s Q1 2018 earnings release on May 3, 2018, the company had announced an expected delay in the approval and launch of Fremanezumab, as shown in the diagram above. This was due to the FDA warning letter received by Teva’s API (active pharmaceutical ingredient) supplier for the drug, Celltrion. The approval was expected by mid-June. We discussed the development in detail in the article An Update on Teva’s Highly Anticipated Migraine Drug.

TEVA stock registered a rise of 1.5%. Peers Amgen (AMGN), Eli Lilly (LLY), and Novartis (NVS) rose 0.9%, 1.4%, and -0.7%, respectively, on the same day.

In the next article, let’s take a look at analysts’ views on the latest update on Fremanezumab approval and the launch of competitive drugs in the market.

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