AbbVie scores FDA nod for continuous Parkinson disease therapy

AbbVie made history in 2015 with its Parkinson disease infusion pump therapy Duopa, kicking off a trend of delivery system innovation in the space as drugmakers sought to avoid the common pitfalls associated with oral treatments.

Now, after multiple delays, the Illinois pharma giant has a new offering on the table as it has scored FDA approval for its more convenient, subcutaneous follow-up Vyalev.

Vyalev, previously known as ABBV-951, features foscarbidopa and foslevodopa, which are the prodrugs for standard-of-care medicines carbidopa and levodopa. Prodrugs are drug derivatives that become active after entering the body. The therapy is delivered as a 24-hour continuous infusion to treat motor fluctuations in adults with advanced Parkinson disease.

AbbVie already markets a carbidopa and levodopa combination with Duopa. That med launched in 2015 as a novel delivery system meant to skirt common downfalls of oral carbidopa/levodopa treatment. Duopa is administered directly to the small intestine through a stomach tube that requires a surgical procedure to put it into place.

Vyalev, meanwhile, is the company's next advance over Duopa. Featuring a pump that’s designed to dole out the treatment continuously under the skin, the delivery tech offers a major convenience edge over its predecessor and still avoids the complications of oral therapies, which stem from a short half-life that make it difficult to control symptoms over time.

"People living with advanced Parkinson's disease experience daily challenges as a result of uncertainty in managing motor fluctuations, especially as their disease progresses," AbbVie’s chief scientific officer Roopal Thakkar, M.D., said in a company release. "We are proud to bring this innovation to patients who may benefit from motor symptom control through continuous 24-hour administration of Vyalev."

The nod comes more than a year after AbbVie’s Vyalev first application was rejected by the FDA and a few months after its second filing was turned away in June. In its initial red light, the agency didn’t raise concern about the combo’s efficacy or safety but requested further information about the subcutaneous pump device.

More recently, the FDA snubbed the therapy after finding issues at a third-party manufacturer listed in AbbVie’s drug application.

Analysts at Evercore ISI previously forecast that Vyalev could be one of AbbVie’s “biggest new product launches over the next year or two,” projecting the product could generate more than $2 billion in peak sales.

In a phase 3 study, the therapy significantly increased patients’ “on” time without dyskinesia—meaning the patients’ involuntary movements were under control—compared with oral levodopa/carbidopa at Week 12. The increase in average “on” time during a 16-hour wake period—over the span of several days—was 2.72 hours for Vyalev-treated patients versus 0.9 hours for the control arm.

Dyskinesia is a common complication of long-term levodopa use in people who have had Parkinson disease for several years.

Even after the delay, AbbVie still beat Mitsubishi Tanabe Pharma Corporation and its own continuous, subcutaneous levodopa/carbidopa combination to the punch. That prospect, which Mitsubishi took on through its 2017 $1.1 billion NeuroDerm acquisition, received a complete response letter from the FDA around the same time as Vyalev’s second rejection.

Meanwhile, Supernus recently received the third FDA rejection for its attempt at an apomorphine (Apokyn) infusion pump, which is meant to treat “off” episodes in patients with Parkinson disease.

Source: News Release
Fierce Pharma
October 17, 2024