Pfizer Inc. PFE announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending marketing authorization for label expansion of Vyndaqel (tafamidis).
The company is seeking approval of once-daily Vyndaqel (61 mg) for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), a rare and fatal illness associated with progressive heart failure.
The CHMP’s opinion will be now reviewed by the European Commission with decision expected in the coming months. If approved, Vyndaqel will become the first pharmacologic therapy to address the given patient population in Europe.
Currently, there are no approved pharmacologic treatments for patients with ATTR-CM. Per the press release, people suffering the disease are diagnosed with life expectancy averaging two to three-and-half years from diagnosis.
The positive CHMP opinion was based on data from the completed phase III study ATTR-ACT, which evaluated oral daily dose of 61 mg Vyndaqel versus placebo in patients with wild-type or hereditary ATTR-CM.
Data from the study showed that treatment with Vyndaqel led to a significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations — the primary endpoint — compared to placebo at 30 months. Moreover, treatment with Vyndaqel led to a 30% reduction in the risk of mortality and 32% lower rate of cardiovascular-related hospitalization as compared to placebo.
Shares of Pfizer have decreased 12.2% so far this year against the industry’s increase of 8.9%.
Vyndaqel is already marketed in Europe for the treatment of transthyretin amyloid polyneuropathy (ATTR-PN) in adult patients with stage I symptomatic polyneuropathy to delay peripheral neurologic impairment.
In May 2019, Vyndaqel and Vyndamax, two oral formulations of tafamidis, were approved in the United States to treat transthyretin cardiomyopathy (TTR-CM). The drug recorded sales of $156 million in the third quarter of 2019.
We remind investors that Alnylam Pharmaceuticals’ ALNY Onpattro (patisiran) is already approved in the United States and Europe for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. The entity is also looking to expand the label of Onpattro into cardiomyopathy. Upon potential approval, this can induce competition for Vyndaqel.
Zacks Rank & Other Stocks to Consider
Pfizer currently carries a Zacks Rank #2 (Buy). Other top stocks in the large cap pharma sector include Merck & Co., Inc. MRK and Bristol-Myers Squibb Co. BMY, both carrying the same Zacks Rank as Pfizer. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Merck’s earnings estimates have moved 5.1% north for 2019 and 2.6% for 2020 over the past 60 days. The stock has rallied 16.7% year to date.
Bristol-Myers’ earnings estimates have been revised 4.4% upward for 2019 and 11.8% for 2020 over the past 60 days. The stock has soared 22.8% so far this year.
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