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The drugs in development include Biogen’s controversial treatment for Alzheimer’s disease and three new drugs for atopic dermatitis.
Among the most notable new drug approvals that might occur this year include a treatment for Alzheimer’s disease and three new drugs for atopic dermatitis, according to a new report.
Pharmacy benefit manager OptumRx’s Drug Pipeline Insights Report identifies aducanumab (Biogen), pegcetacoplan (Apellis Pharmaceuticals), abrocitinib (Pfizer), tralokinumab (LEO Pharma) and ruxolitinib (Incyte Corporation) as the top 5 drugs in the pipeline.
Aducanumab, which is awaiting the results of an FDA committee’s safety review in early June, is a human monoclonal antibody under development to treat Alzheimer’s disease.
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“Several prescription drugs are currently approved to treat the symptoms of Alzheimer’s such as memory loss. If approved, aducanumab would be the first disease modifying therapy for Alzheimer’s disease,” the report said.
But an advisory committee to the FDA vote against approving aducanumab late last year, and a number of experts have questioned how Biogen is interpreting clinical trial data to support its application.
Abrocitinib is under development to treat moderate-to-severe atopic dermatitis in patients aged 12 years and older. The Janus kinase (JAK) inhibitor medication helps ease inflammation and other related symptoms.
Tralokinumab is another drug for atopic dermatitis, but it acts on interleukin (IL)-13, which plays a key role in driving the underlying chronic inflammation in atopic dermatitis.
In Phase 3 trials, patients were treated with tralokinumab administered subcutaneously every 2 or 4 weeks, and with or without a topical corticosteroid. The results demonstrated efficacy and safety at each interval, with or without the use of a topical corticosteroid.
“If approved, tralokinumab would offer a novel mechanism of action for moderate-to-severe atopic dermatitis. However…tralokinumab will compete not only with existing treatment options like Dupixent but also, potentially, several JAK inhibitors as well,” said the OptumRx report.
Ruxolitinib topical cream will treat mild-to-moderate atopic dermatitis in patients aged 12 years and older. The selective JAK inhibitor directly targets two chemical pathways that underlie atopic dermatitis.
If approved, the medication would be the first topical JAK inhibitor for atopic dermatitis. “While oral JAK inhibitors have been associated with serious side effects, the topical form may potentially reduce some of the safety concerns associated with the class. According to the data available, topical ruxolitinib appears to be well tolerated with no major safety issues,” said report from OptumRx, which is a subsidiary of UnitedHealth Group.
Ruxolitinib is currently available as an oral brand (Jakafi) to treat myelofibrosis, polycythemia vera, and graft vs. host disease.
Pegcetacoplan is under development to treat a rare condition, paroxysmal nocturnal hemoglobinuria, which causes the immune system to attack and break down healthy red bloods cells, leading to anemia.
If approved, pegcetacoplan would be the first treatment for the disease to target a different portion of the complement cascade. “There are several differences among these drugs some of which could lead to pegcetacoplan becoming a new market leader for the treatment of PNH,” said OptumRx report.