Valeant constipation drug approved in US
Valeant and Progenics’ Relistor (methylnatrexone) opioid-induced constipation drug has been approved in pill form, potentially giving the companies a blockbuster gastrointestinal drug.
Canada’s Valeant also received a further boost after advisers to the FDA recommended approval for its psoriasis drug, brodalumab.
Relistor had previously been available in injectable form, but the oral form of the drug has been tipped to push sales north of a billion dollars annually.
The latest approval is for non-cancer pain, so oncology patients with opioid induced constipation will still take the injectable version.
Relistor will be available in 450mg tablets, taken once daily. It was approved in 2008 for OIC in cancer pain and in 2014 for the non-cancer pain indication.
Asset managers Guggenheim backed the drug to become a blockbuster at the beginning of the month.
Progenics originally developed the drug, and sold the rights to Salix in all territories apart from Japan back in 2011.
Valeant gained the rights to the drug after it bought Salix in 2015 for $11 billion – and looks likely to start getting returns on this investment, expecting to launch the drug in Q3.
Relistor already has a competitor – Daiichi Sankyo and AstraZeneca’s Movantik (naloxegol) is available in pill form and is approved in the non-cancer indication in the US. But the drug has hardly been a stellar performer since its US launch last year, and Q1 sales were just $17 million.
Valeant is rebuilding after a disastrous spell that saw it at the centre of investigations into its pricing and its ties to the mail-order pharmacy, Philidor.
The unanimous 18-0 vote from the Dermatologic and Ophthalmic Drugs Advisory Committee in favour of approving brodalumab will also help matters.
Although the vote is non-binding the FDA usually follows the advice of its committees.
Indicated for moderate-to-severe plaque psoriasis, the committee recommended a risk management plan for brodalumab.
Valeant bought the rights to the drug from AstraZeneca last year, after a troubled development where it has been linked to suicidal ideation.
AZ continued to develop the drug after Amgen decided to pull out because of the suicidal ideation link.
The drug, which binds to the interleukin-17 receptor and prevents its activation, is also under review in Europe, where it will be marketed by LEO Pharma if approved.