We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Pfizer Gets CHMP Nod for Vyndaqel Label Expansion in Europe
Read MoreHide Full Article
Pfizer Inc. (PFE - Free Report) 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 - Free Report) 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.
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.
Today's Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through Q3 2019, while the S&P 500 gained +39.6%, five of our strategies returned +51.8%, +57.5%, +96.9%, +119.0% and even +158.9%.
This outperformance has not just been a recent phenomenon. From 2000 – Q3 2019, while the S&P averaged +5.6% per year, our top strategies averaged up to +54.1% per year.
Image: Bigstock
Pfizer Gets CHMP Nod for Vyndaqel Label Expansion in Europe
Pfizer Inc. (PFE - Free Report) 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 - Free Report) 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 - Free Report) and Bristol-Myers Squibb Co. (BMY - Free Report) , 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.
Today's Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through Q3 2019, while the S&P 500 gained +39.6%, five of our strategies returned +51.8%, +57.5%, +96.9%, +119.0% and even +158.9%.
This outperformance has not just been a recent phenomenon. From 2000 – Q3 2019, while the S&P averaged +5.6% per year, our top strategies averaged up to +54.1% per year.
See their latest picks free >>