This wasn’t a big surprise. An expert panel offered a lopsided 9-to-1 vote in its favor, happy to see a new drug would be a welcome addition to the pharmacopeia available for the eye disease.
That vote came on the heels of an insider FDA review that concluded the drug reduced elevated intraocular pressure in the eye — the key task in the field. But the review also noted that the comparator drug, the generic timolol ophthalmic solution 0.5% twice daily, was more effective for the more severely afflicted patients.
About the last potential threat to the drug approval was erased in early November when the FDA cleared a new drug from Valeant intended to be manufactured in the same Bausch + Lomb facility in Tampa, FL that had been sanctioned twice for regulatory shortcomings. Once the facility got a stamp of approval, Aerie’s drug looked like a lock.
It didn’t escape several observers’ attention today that the early OK brought the FDA’s record on new approvals to 43 for the year, just two back from the 10-year high of 45 hit in 2015. New approvals are running at twice the level hit last year after the industry saw a slump in NDAs.
A bullish Aerie CEO Vicente Anido has already touted Rhopressa as a likely blockbuster able to earn more than $1 billion a year, even though the biotech had to get the FDA’s permission to change the endpoint for its second late-stage study of Rhopressa in order to avoid back-to-back failures.
Anido, not one to underplay a sentiment, called the approval “the single greatest achievement” so far for the company.
“We have been preparing for commercialization for well over a year, and our plans are clear,” he added in a statement. “We will hire our sales force of 100 sales representatives early in the first quarter of 2018, and plan to launch by mid-second quarter of 2018. As the 2018 year progresses, it is our goal to make strides in gaining formulary coverage for commercial plans, which represent approximately half of the U.S. market. The other half of the U.S. market is covered through Medicare Part D, and we expect our formulary presence for this market to commence in January 2019.”
Next up: Aerie has a followup drug called Roclatan, a combo drug that combines the generic latanoprost to its in-house drug Rhopressa. That drug will be filed in Q2, says Anido.
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