Valeant, Ocular Therapeutix get CRLs tied to manufacturing

Just days after Valeant Pharmaceuticals' plans for a new eye drug were upended by a complete response letter (CRL) tied to its manufacturing operations, Ocular Therapeutix got one as well. In fact, it is the fourth time this year that a drug approval has been sidelined because the FDA was not satisfied with the manufacturing facility in which the drug was to be produced.

On Friday, Valeant ($VRX) announced that the FDA had turned away a new drug application for its latanoprostene bunod ophthalmic solution, a candidate therapy for open-angle glaucoma or ocular hypertension, citing deficiencies at a manufacturing plant in Tampa, FL, operated by Valeant’s Bausch + Lomb unit. Canada-based Valeant said the FDA concerns were only about deficiencies identified at the plant, not the efficacy or safety of the drug. But it is a significant setback for Valeant as it tries to shift toward more R&D-related efforts. The company has indicated the eye drug could be $1 billion seller.

Then on Monday, Ocular said it had also received a CRL for its NDA for Dextenza, a treatment for post-ophthalmic surgery pain. It said the letter was tied to manufacturing process and controls concerns that arose during the pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility in Bedford, MA. Like Valeant, the eye-treatment specialist emphasized that the FDA did not mention problems with the efficacy or safety of the drug. The FDA didn’t ask for more clinical trials.

Nonetheless, as Ocular pointed out, the drug will not be approved until it resolves the manufacturing deficiencies identified during the FDA facility inspection. It said it had responded to the FDA issues and that “We remain optimistic that Dextenza will be approved once these open manufacturing items are closed,” the company said.

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There have now been a series of these letters. In May, AstraZeneca ($AZN) said it had received a CRL for its investigational treatment for hyperkalemia, a drug candidate that was the target of AstraZeneca’s $2.7 billion buyout of ZS Pharma. This was also tied to manufacturing problems.

Before that, Miami-based OPKO ($OPK) received a CRL because of issues the FDA had with the manufacturing plant in Florida where its drugs are being manufactured by Catalent ($CTLT). While the issues were not specific to the production of the OPKO product Rayaldee, the FDA had 14 general observations about the plant.

OPKO’s case offers hope for the other drugmakers. The CRL was issued in March, and by June, the company and Catalent had satisfied the agency and the FDA approved the treatment for secondary hyperparathyroidism.

- here’s Ocular’s press release
- and Valeant’s announcement 

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Manufacturing issues undermine AstraZeneca's $2.7B drug play 
OPKO wins FDA approval for Rayaldee after Catalent quickly resolves plant concerns