Valeant indicates Bausch plant responsible for CRL now ready to go

Valeant says it has a new PDUFA date for the eye drug for which it was issued a complete response letter last year because of problems at the plant where it is being produced.

Valeant Pharmaceuticals International said today that it has gotten a new PDUFA date for its eye drug candidate latanoprostene bunod, indicating that Valeant thinks the Bausch + Lomb plant that will make it is ready for prime-time production. The FDA issued Valeant a complete response letter last year for the drug because of shortcomings it found at the plant.

Valeant said the FDA has set an Aug. 24 date for its decision on its NDA for latanoprostene bunod. The ophthalmic solution, which Bausch + Lomb licensed from Paris-based Nicox, can lower intraocular pressure for patients with open angle glaucoma or ocular hypertension.

Before the drug was sidelined by manufacturing problems, the beleaguered Valeant predicted it could be a billion-dollar seller. When the FDA issued the CRL in September, Valeant said the agency didn't have any efficacy issues or safety concerns about the drug candidate.

The FDA did have concerns with the Bausch plant in Tampa, Florida, where it the solution is being produced. A Form 483 shows that investigators were in the facility for nearly three weeks in February 2016. Among issues noted were problems on the filling line for ophthalmic solutions, where investigators noted on 20 occasions that plant employees investigated nonconformance readings but never got to the root of the problem so that they could prevent further incidences.

The fact that Valeant has won a new PDUFA date for the drug suggests that it has had more luck getting plant issues under control than AstraZeneca’s ZS Pharma unit. AstraZeneca announced last week that the FDA had issued a second CRL for ZS 9, a potential blockbuster treatment for hyperkalemia that was the target of AstraZeneca’s $2.7 billion buyout of ZS Pharma in 2015. It said the agency was still not satisfied with the manufacturing process being used to produce the drug.