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Merck, AbbVie & Amgen Drugs a Step Closer to EU Approval
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Merck & Co. Inc. (MRK - Free Report) , AbbVie Inc. (ABBV - Free Report) and Amgen Inc. (AMGN - Free Report) are all a step closer to gaining EU approval for their regulatory applications for Zepatier, Humira and Kyprolis, respectively. The companies announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions regarding their respective drugs.
CHMP Positive on Merck’s HCV Drug, Zepatier
Merck is looking to get its hepatitis C virus treatment, Zepatier, approved in the EU. Zepatier is already approved in the U.S. where it was launched earlier this year with first quarter 2016 sales coming in at $50 million. With the CHMP issuing a positive opinion, approval should come in mid-2016.
Merck said that it continues to work on achieving manufacturing readiness to supply the EU market. On its first quarter call, the company had said that the EMA cited Merck's third-party manufacturer for issues largely related to inadequate record keeping and the need for improvement in their quality management systems.
The company currently expects the European launch in the fourth quarter of 2016 or the first quarter of 2017.
Positive Opinion for AbbVie’s Humira Label Expansion
AbbVie is looking to expand the label of its flagship product, Humira, for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids or in whom corticosteroid treatment is inappropriate.
Approval would make Humira the first biologic treatment option in the EU for certain patients with non-infectious intermediate, posterior and panuveitis.
Currently approved for several indications, Humira is AbbVie’s top revenue grosser with 2015 sales coming in at $14 billion. The product continues to see strong growth in the dermatology and gastroenterology markets.
Amgen’s Kyprolis Gets Positive CHMP Opinion
Amgen’s cancer treatment, Kyprolis, also got a positive CHMP opinion for expanding the label to include treatment in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy.
Kyprolis’ label was expanded in the U.S. earlier this year for this indication. With both the ASPIRE and ENDEAVOR data in its U.S. label, Kyprolis looks well-positioned to gain share.
Merck and Amgen are both Zacks Rank #3 (Hold) stocks while AbbVie is a Zacks Rank #5 (Strong Sell) stock. A better-ranked stock in the health care sector is Pfizer, Inc. (PFE - Free Report) , a Zacks Rank #1 (Strong Buy) company.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >>
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Merck, AbbVie & Amgen Drugs a Step Closer to EU Approval
Merck & Co. Inc. (MRK - Free Report) , AbbVie Inc. (ABBV - Free Report) and Amgen Inc. (AMGN - Free Report) are all a step closer to gaining EU approval for their regulatory applications for Zepatier, Humira and Kyprolis, respectively. The companies announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions regarding their respective drugs.
CHMP Positive on Merck’s HCV Drug, Zepatier
Merck is looking to get its hepatitis C virus treatment, Zepatier, approved in the EU. Zepatier is already approved in the U.S. where it was launched earlier this year with first quarter 2016 sales coming in at $50 million. With the CHMP issuing a positive opinion, approval should come in mid-2016.
Merck said that it continues to work on achieving manufacturing readiness to supply the EU market. On its first quarter call, the company had said that the EMA cited Merck's third-party manufacturer for issues largely related to inadequate record keeping and the need for improvement in their quality management systems.
The company currently expects the European launch in the fourth quarter of 2016 or the first quarter of 2017.
Positive Opinion for AbbVie’s Humira Label Expansion
AbbVie is looking to expand the label of its flagship product, Humira, for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids or in whom corticosteroid treatment is inappropriate.
Approval would make Humira the first biologic treatment option in the EU for certain patients with non-infectious intermediate, posterior and panuveitis.
Currently approved for several indications, Humira is AbbVie’s top revenue grosser with 2015 sales coming in at $14 billion. The product continues to see strong growth in the dermatology and gastroenterology markets.
Amgen’s Kyprolis Gets Positive CHMP Opinion
Amgen’s cancer treatment, Kyprolis, also got a positive CHMP opinion for expanding the label to include treatment in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy.
Kyprolis’ label was expanded in the U.S. earlier this year for this indication. With both the ASPIRE and ENDEAVOR data in its U.S. label, Kyprolis looks well-positioned to gain share.
Merck and Amgen are both Zacks Rank #3 (Hold) stocks while AbbVie is a Zacks Rank #5 (Strong Sell) stock. A better-ranked stock in the health care sector is Pfizer, Inc. (PFE - Free Report) , a Zacks Rank #1 (Strong Buy) company.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>