Plaque psoriasis drug approved with strong suicidal ideation warning

black box warning graphic WL Plaque psoriasis drug approved with strong suicidal ideation warningThe recently approved anti-inflammatory plaque psoriasis drug Siliq (brodalumab) will hit the market later this year facing major hurdles, including a black box warning, restrictive prescribing protocols, and steep competition.

The development of Siliq came out of a partnership between Amgen and AstraZeneca. In 2015, Amgen backed out of the deal after observing suicidal ideation in patients who were treated with the drug during clinical trials. Amgen feared the drug would not only have a difficult road to approval due to the suicide risk, if it were approved, it would come with restrictive labeling.

AstraZeneca then struck a deal with Valeant and the two applied for Food and Drug Administration (FDA) approval. Last summer, an FDA advisory panel recommended approval of Siliq despite six observed suicides in patients treated with Siliq during clinical trials. The FDA is not required to follow the recommendations of its advisory panel, but it usually does. And in the case of Siliq, it did.

But true to Amgen’s concerns, the approval came with strings attached. The drug will carry a black box warning – the most serious warning the FDA requires – regarding suicidal thoughts. The FDA also required the drug be in a REMS program, which requires that only REMS-certified doctors can prescribe Siliq and that doctors counsel patients on the risk of suicide. Patients will also be required to sign a consent form. And, only REMS-certified pharmacies can dispense the drug.

Siliq labeling will also state that the drug is contraindicated for patients with Chrohn’s disease and recommend that doctors screen patients for tuberculosis before prescribing the drug.

If that weren’t enough, Siliq will hit the market during the second half of 2017 facing steep competition from Novartis’ Cosentyx (secukinumab) and Eli Lilly’s Taltz (ixekizumab). Cosentyx was approved in 2015 and racked up sales of $1.13 billion in 2016. Taltz, which was approved last March, brought in about $113 million in 2016.

Source: BioPharma Dive