Pfizer's Cardiomyopathy Drug Vyndaqel Gets Approval In Europe

Pfizer, Inc. (NYSE:PFE) announced that the European Commission has granted approval to C(tafamidis) capsule to treat wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), a rare and fatal illness associated with progressive heart failure.

With the approval, Vyndaqel (61 mg) becomes the first pharmacologic therapy approved to treat ATTR-CM in Europe. Per the press release, people suffering from the disease have life expectancy averaging two to three-and-half years from diagnosis.

Pfizer’s shares have declined 14% in the past year against an increase of 9.2% for the industry.

The approval was expected as in December the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) had recommended approval to Vyndaqel. The approval was based on data from the completed phase III study ATTR-ACT, which evaluated oral daily dose of 20 mg or 80 mg of tafamidis meglumine versus placebo in patients with wild-type or hereditary ATTR-CM. Vyndaqel has been marketed in Europe since 2011 for the treatment of transthyretin amyloid polyneuropathy (ATTR-PN) in adult patients with stage I symptomatic polyneuropathy to delay peripheral neurologic impairment.

Vyndaqel and Vyndamax, two oral formulations of tafamidis, were approved in the United States in May last year for ATTR-CM. While Vyndaqel was launched in May 2019, Vyndamax was launched in September. The drugs are off to a strong start and recorded sales of $473 million in 2019.

We remind investors that Alnylam Pharmaceuticals’ (NASDAQ:ALNY) Onpattro (patisiran) is also approved in the United States and Europe for the treatment of hereditary TTR amyloidosis, or hATTR.

There are two types of TTR-CM, a hereditary form and a wild-type form, which is not hereditary. While Vyndaqel is approved to treat both types of patients, Onpattro is approved only for the hereditary form of the disease. Meanwhile, Akcea Therapeutics, Inc. (NASDAQ:AKCA) and partner Ionis Pharmaceuticals (NASDAQ:IONS) are developing AKCEA-TTR-LRx for hereditary and wild-type forms of ATTR amyloidosis.

Pfizer currently sports a Zacks Rank #1 (Strong Buy). You can seethe complete list of today’s Zacks #1 Rank stocks here.

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