AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump

In what’s expected to be one of AbbVie’s “biggest new product launches” in the coming years, the company has hit a snag with its regulatory efforts.

The FDA has rejected AbbVie’s application for ABBV-951 for controlling motor fluctuations in patients with advanced Parkinson’s disease, the company said Wednesday.

The treatment is a combination of foscarbidopa and foslevodopa, the prodrugs for the widely used carbidopa and levodopa, respectively, which are already included in AbbVie’s Duopa. Prodrugs are versions of medications that become active once inside the body.

The FDA didn’t raise any questions about ABBV-951’s efficacy or safety, but it requested additional information about the combo’s subcutaneous pump device, AbbVie said. The Illinois pharma giant said it plans to resubmit the application as soon as possible.

ABBV-951 could be one of AbbVie’s “biggest new product launches over the next year or two,” analysts at Evercore ISI said in a Wednesday note. An approval should eventually come, but the analysts pushed back their estimated launch timeline by a year to mid-2024.

Compared with Duopa, ABBV-951 could offer improved convenience and efficacy. While Duopa comes in a gel form and is administered orally with a pump through a stomach tube, ABBV-951 is designed to be given continuously under the skin via a pump. Before starting Duopa, surgery is required to place the tube in the patient’s intestine, and doctors have described the process as quite cumbersome, according to the Evercore analysts.

In a randomized phase 3 trial, ABBV-951 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 “on” time at that point in the trial was 2.72 hours for ABBV-951 versus 0.96 hours for the control arm.

Considering ABBV-951’s convenience edge and efficacy profile as shown in the phase 3 trial, Clarivate recently named the combo as one of 15 drugs to watch in 2023, with expected sales of $880 million in 2027. By comparison, Duopa generated $458 million in worldwide sales in 2022, down 2% year over year at constant currencies.

On average, Wall Street analysts have projected ABBV-951’s peak sales will reach $1 billion. But the Evercore team said they “wouldn’t be surprised” if the drug can eventually hit more than $2 billion.

But the FDA rejection diminishes a potential lead for AbbVie over Mitsubishi Tanabe Pharma’s ND-0612, which is also a continuous subcutaneous infusion but of liquid levodopa/carbidopa. The Japanese company bought ND-0612 through its $1.1 billion acquisition of NeuroDerm in 2017.

NueroDerm announced in January that a trial of ND0612 also hit its goal, showing significant improvement in “on” time for ND0612 over oral levodopa/carbidopa. Detailed data from the study remain under wraps, and Evercore’s analysts suggest it could reach the market in mid-2024 at the earliest.

AbbVie still has a few edges over its potential rival. As Clarivate noted in its Drugs to Watch Report, ND0612 offers only one strength and requires two insertion sites. Besides, as the Evercore team noted, AbbVie already has experience in the market thanks to an existing field force for Duopa.