FDA, New Products

Aralez finally gets an FDA OK for its cardio drug Yosprala, starts hiring sales reps


The third time proved the charm for Aralez Pharmaceuticals. After two years of back and forth with the FDA over a serious manufacturing snafu, the agency has finally given its thumbs up to the biotech’s cardio drug Yosprala.

The approval clears the way for the Canadian company to add 85 sales reps to its commercialization arm. Yosprala is approved for “patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.”

Back at the end of 2014, the biotech $ARLZ, then called Pozen, disappointed investors for the second time when they said that the FDA had once again spurned Yosprala citing the same manufacturing deficiencies that had triggered to first rejection earlier in the year. At the time, the company assured investors that all was well.

Their drug is a combo of aspirin and the proton pump inhibitor omeprazole, and it’s supposed to reduce the risk of cardio events.

At the end of last year, the company says that its primary, unidentified, supplier was still not compliant with the FDA and had agreed to stop making drugs at the troubled facility. And it moved its secondary supplier into the primary position.

The addition of 85 new reps will bring its sales force up to 110. Aralez recently acquired Merck’s flailing clot-fighting drug Zontivity for $25 million.

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