The US Food and Drug Administration has rejected Valeant group Ortho Dermatologics’ plaque psoriasis therapy Duobrii.
The agency’s complete response letter raised questions regarding the drug’s pharmacokinetic data, but did not specify any deficiencies relating to clinical efficacy or safety, the firm stressed.
"We are working to resolve this matter expeditiously and have already requested a meeting with the FDA,” said Joseph Papa, chairman and chief executive of Valeant.
“We hope to bring forward this important new treatment option for those who suffer from plaque psoriasis as quickly as possible”.
Valeant’s shares were trading down around 7 percent after the announcement, but Mizuho analyst Irina Koffler believes that Duobrii’s sales estimate of $175 million by 2022 it “still achievable” if the firm can quickly address the FDA’s concerns, reports The Globe and Mail.
Around 7.5 million in the US are thought to suffer from psoriasis, an inflammatory skin disease.