Valeant gets an FDA OK for new psoriasis drug brodalumab — but there’s a big catch – ENDPOINTS NEWS stat : endpts
The FDA has come through with an approval for Valeant's psoriasis drug brodalumab. Then it became evident the drug spurred suicidal thoughts among patients – some of whom went on to kill themselves. "Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment." At one point both AstraZeneca $AZN and Amgen $AMGN thought they were on to a new blockbuster as they started Phase III on brodalumab. But they've hobbled it with a black box safety warning on suicidal ideation and a risk mitigation marketing program that will likely hobble its revenue in an intensely competitive market.
Valeant shares have declined 5.6% over the last three months, compared with a 7.9% rise in the S&P 500 SPX, -0.24% Valeant Pharmaceuticals International Inc. VRX, -3.05% shares surged as much as 3.1% in pre-market trade Thursday after the company said its plaque psoriasis injection had been approved by the Food and addiction Administration. Valeant said it expects to begin sales and marketing for Siliq in the second half of 2017. AztraZeneca AZN, -0.07% -- which granted Valeant the right to develop and commercialize Siliq in most countries globally -- will receive $130 million in a milestone payment, Dow Jones reports. Siliq, which is intended for patients with moderate-to-severe iterations of the chronic skin condition who haven't responded to other therapies, will have a "black box warning" about risks for patients with a history of suicidal thoughts or behavior, Valeant said.
The most common form of psoriasis is plaque psoriasis, in which patients develop thick, red skin with flaky, silver-white scales. The U.S. Food and addiction Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. "Moderate-to-severe plaque psoriasis can cause significant skin irritation and discomfort for patients, and today's approval provides patients with another treatment option for their psoriasis," said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. Psoriasis is a skin condition that causes patches of skin redness and flaking. A causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established.
collected by :Lucy William
Valeant shares have declined 5.6% over the last three months, compared with a 7.9% rise in the S&P 500 SPX, -0.24% Valeant Pharmaceuticals International Inc. VRX, -3.05% shares surged as much as 3.1% in pre-market trade Thursday after the company said its plaque psoriasis injection had been approved by the Food and addiction Administration. Valeant said it expects to begin sales and marketing for Siliq in the second half of 2017. AztraZeneca AZN, -0.07% -- which granted Valeant the right to develop and commercialize Siliq in most countries globally -- will receive $130 million in a milestone payment, Dow Jones reports. Siliq, which is intended for patients with moderate-to-severe iterations of the chronic skin condition who haven't responded to other therapies, will have a "black box warning" about risks for patients with a history of suicidal thoughts or behavior, Valeant said.
The most common form of psoriasis is plaque psoriasis, in which patients develop thick, red skin with flaky, silver-white scales. The U.S. Food and addiction Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. "Moderate-to-severe plaque psoriasis can cause significant skin irritation and discomfort for patients, and today's approval provides patients with another treatment option for their psoriasis," said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. Psoriasis is a skin condition that causes patches of skin redness and flaking. A causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established.
collected by :Lucy William
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