Merck & Co., Inc. MRK announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion, recommending marketing approval for an improved dosing schedule of its blockbuster anti-PD-1 therapy, Keytruda.
The CHMP nod supports approval of a six-week 400 mg dosing option of Keytruda for all eight approved monotherapy indications across five tumor types in Europe. The new recommended dose will be delivered as an intravenous infusion over 30 minutes and will provide greater flexibility than the currently approved dose of 200 mg every three weeks infused over 30 minutes. Merck’s application will now be reviewed by the European Commission, which will announce its decision in the second quarter of this year.
Merck’s stock has risen 6.5% this year so far compared with a 3.8% increase for the industry.
In a very short span of time, Keytruda has become Merck’s biggest product. It is now already approved for use in 15 indications across 10 different tumor types in the United States. The drug generated sales of $7.17 billion in 2018, reflecting a massive 88% surge year over year. Keytruda is continuously growing and expanding into new indications and markets globally.
The Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 900 studies, including more than 500 combination studies. Merck is collaborating with several companies including Amgen AMGN, Incyte INCY, Glaxo GSK and Pfizer separately for the evaluation of Keytruda in combination with other regimens.
We believe that Keytruda has strong growth prospects based on increased utilization, recent approvals for new indications and potential additional approvals worldwide.
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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