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By Toni Clarke
July 19 (Reuters) - Valeant Pharmaceuticals InternationalInc's experimental drug to treat the skin disorderpsoriasis should be approved as long as certain measures are putin place to mitigate the risk of suicide, an advisory committeeto the U.S. Food and Drug Administration concluded on Tuesday.
The FDA is not obliged to follow the advice of its advisorycommittees but typically does so.
In clinical trials of the drug, brodalumab, there were sixsuicides across all programs: four in psoriasis studies, one ina rheumatoid arthritis study and one in a psoriatic arthritisstudy. Even so, the committee voted 18-0 that the drug should beapproved, saying the benefit outweighed the potential risk.
Of those, 14 voted that the drug should only be prescribedalongside a strong risk management program that goes beyondsimply including the information in the label. Such programs caninclude medication guides and communications plans forhealthcare providers.
Panelists said there was a need for new drugs for psoriasisand they would like to have brodalumab available as an option.They offered various suggestions about how to mitigate thesuicide risk, including a boxed warning and a patient registryto collect patient data and more clearly assess suicide risk.
Some thought the registry should be mandatory and othersthought it should be voluntary. Some thought any registry wouldcreate unnecessary barriers to accessing the drug and may notreflect a true estimate of the suicide risk.
Valeant itself has a risk management proposal that includesparticipation in a registry and enhanced communication but noboxed warning.
Brodalumab blocks a cell receptor known as interleukin-17 totamp down inflammation. Several other IL-17 inhibitors arealready on the market, including Cosentyx from NovartisAG and Taltz from Eli Lilly & Co. The drug wouldalso compete with Amgen's Enbrel, Johnson & Johnson's Remicade and AbbVie's Humira.
About 7.5 million people in the United States suffer frompsoriasis, according to the American Academy of Dermatology. Thedisorder, characterized by raised, scaly skin patches, can beassociated with other conditions, including diabetes and heartdisease.
Brodalumab was initially developed by AstraZeneca Plc and Amgen Inc. In May, 2015, Amgen withdrew from the partnershipbecause of the suicides.
AstraZeneca subsequently licensed global rights to the drugto Valeant, whose fortunes have plummeted over the past yearamid criticism of its high drug prices and cloudy relationshipwith a specialty pharmacy. (Reporting by Toni Clarke in Washington; Editing by Alan Crosbyand David Gregorio)
