UCB SA won Food and Drug Administration approval for its psoriasis drug, although risks flagged by the regulator prompted shares to reverse initial gains.
(Bloomberg) — UCB SA won Food and Drug Administration approval for its psoriasis drug, although risks flagged by the regulator prompted shares to reverse initial gains.
The FDA decision came with a warning that the drug may increase the risk of suicidal ideation and behavior, while no causal association was established, according to a statement Wednesday. The regulator also cautioned on risks of infections, increased liver enzymes and for patients with tuberculosis.
UCB shares reversed earlier gains and dropped as much as 5.5% to €74.62, the lowest level since March.
“The presence of two unexpected warnings on the label (suicidal ideation and behavior and elevated liver enzymes) will likely to be a topic of debate, with investors pondering the weight of these warnings on the uptake of the drug in the US,” Morgan Stanley analysts including Thibault Boutherin wrote in a note.
The Belgian biotech company had faced delays in seeking US clearance for the medicine, which is already approved in other countries including UK, Canada and in Europe under the brand name Bimzelx. UCB will now seek approval for additional applications, according to Emmanuel Caeymaex, executive vice president for immunology solutions and head of US.
Sales of the drug have rapidly grown since its launch during the pandemic, reaching €52 million in the first half. The company expects global peak sales for Bimzelx at least €4 billion ($4.2 billion), above some analysts estimates. In a separate statement, UCB said it also got FDA clearance for its Zilbrysq medicine for some patients with generalized myasthenia gravis.
“We fear the psoriasis launch will lag expectations through 2024,” Citigroup analysts including Peter Verdult wrote in a note, also citing the warning label and other drugs currently available in the US market.
UCB’s Approvals Uphold Prospects, Bimzelx Label Blemished: React
As many as 91% of patients treated with the psoriasis medicine achieved clear or almost clear skin at week 16 in a late-stage trial, the company said in a, with 59% to 68% getting complete clearance. The disease affects more than 7.5 million adults in the US.
–With assistance from Michael Msika and Lisa Pham.
(Updates with warning label in second paragraph, shares in third.)
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