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Merck/Pfizer's Diabetes Drug Accepted for Review by FDA, EMA
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Merck & Co., Inc. (MRK - Free Report) and partner Pfizer, Inc. (PFE - Free Report) announced that the FDA has accepted its new drug applications (NDA) for its diabetes candidate, ertugliflozin as a monotherapy as well as two fixed-dose combination tablets.
The companies had filed three NDAs with the FDA, one as a monotherapy and one each for fixed-dose combinations ertugliflozin/Januvia and ertugliflozin/metformin. The FDA is expected to announce its decision in December this year. Meanwhile, the European Medicines Agency (EMA) has also validated the three marketing applications.
Merck’s shares have been up 12% so far this year, comparing favorably with an increase of 6.2% witnessed by the Zacks classified Large-Cap Pharma industry, backed by consistently strong earnings results, and regular positive news flow and regulatory updates.
Ertugliflozin is an investigational oral sodium glucose cotransporter (SGLT2) inhibitor to help improve glycemic control in type 2 diabetes patients.
The marketing applications to both the FDA and the EMA were based on data from studies in the VERTIS clinical development program, which comprised nine phase III trials in approximately 12,600 adults.
In September last year, Merck/Pfizer had announced that the VERTIS SITA2 phase III study on ertugliflozin met the primary endpoint. The double-blind, randomized, placebo-controlled study showed that ertugliflozin (both 5 mg and 15 mg daily doses), when added to sitagliptin and metformin, led to A1C reduction in patients with type 2 diabetes. While the 5-mg dose reduced A1C by 0.69%, the 15 mg dose led to a 0.76% decline in A1C. The drug met the key secondary endpoints of the trial as well. Overall adverse event (AE) rates were also low in both the dosage arms of ertugliflozin compared to placebo.
Merck diabetes franchise includes drugs like Januvia and Janumet (Januvia+ metformin HCl). The Januvia franchise (Januvia+Janumet) is facing pricing pressure due to higher discounts and rebates to maintain good managed care coverage. The franchise recorded sales of $1.51 billion in the fourth quarter of 2016, up 4% from the year-ago quarter as higher sales in the U.S. offset lower sales in Japan. In 2016, the franchise’s sales were $6.1 billion, up 2% year over year.
Note that the diabetes space is highly crowded with drugs like Eli Lilly & Company’s (LLY - Free Report) Tradjenta and Jardiance and Novo Nordisk A/S’s (NVO - Free Report) Victoza and Tresiba among others.
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Merck/Pfizer's Diabetes Drug Accepted for Review by FDA, EMA
Merck & Co., Inc. (MRK - Free Report) and partner Pfizer, Inc. (PFE - Free Report) announced that the FDA has accepted its new drug applications (NDA) for its diabetes candidate, ertugliflozin as a monotherapy as well as two fixed-dose combination tablets.
The companies had filed three NDAs with the FDA, one as a monotherapy and one each for fixed-dose combinations ertugliflozin/Januvia and ertugliflozin/metformin. The FDA is expected to announce its decision in December this year. Meanwhile, the European Medicines Agency (EMA) has also validated the three marketing applications.
Merck’s shares have been up 12% so far this year, comparing favorably with an increase of 6.2% witnessed by the Zacks classified Large-Cap Pharma industry, backed by consistently strong earnings results, and regular positive news flow and regulatory updates.
Ertugliflozin is an investigational oral sodium glucose cotransporter (SGLT2) inhibitor to help improve glycemic control in type 2 diabetes patients.
The marketing applications to both the FDA and the EMA were based on data from studies in the VERTIS clinical development program, which comprised nine phase III trials in approximately 12,600 adults.
In September last year, Merck/Pfizer had announced that the VERTIS SITA2 phase III study on ertugliflozin met the primary endpoint. The double-blind, randomized, placebo-controlled study showed that ertugliflozin (both 5 mg and 15 mg daily doses), when added to sitagliptin and metformin, led to A1C reduction in patients with type 2 diabetes. While the 5-mg dose reduced A1C by 0.69%, the 15 mg dose led to a 0.76% decline in A1C. The drug met the key secondary endpoints of the trial as well. Overall adverse event (AE) rates were also low in both the dosage arms of ertugliflozin compared to placebo.
Merck diabetes franchise includes drugs like Januvia and Janumet (Januvia+ metformin HCl). The Januvia franchise (Januvia+Janumet) is facing pricing pressure due to higher discounts and rebates to maintain good managed care coverage. The franchise recorded sales of $1.51 billion in the fourth quarter of 2016, up 4% from the year-ago quarter as higher sales in the U.S. offset lower sales in Japan. In 2016, the franchise’s sales were $6.1 billion, up 2% year over year.
Note that the diabetes space is highly crowded with drugs like Eli Lilly & Company’s (LLY - Free Report) Tradjenta and Jardiance and Novo Nordisk A/S’s (NVO - Free Report) Victoza and Tresiba among others.
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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