- Allergan, fresh off getting acquired by AbbVie, disclosed Friday that the Food and Drug Administration decided not to approve an eye medicine the company once viewed as integral to its future growth.
- Allergan and Molecular Partners, a Swiss drugmaker, have been testing whether abicipar can treat an age-related eye disease known as wet AMD, a common form of vision loss affecting millions of Americans. The two have been hoping to show that abicipar might be a viable challenger to the injectible medicines, like Eylea, that generate billions of dollars in sales each year.
- Clinical tests found that, while effective, abicipar caused more inner eye inflammation than similar treatments. It was this safety signal, according to AbbVie, which led the FDA to conclude abicipar's risks outweigh its benefits. The company said it plans to meet with the agency to discuss the next steps for its drug.
A few years ago, abicipar was one of Allergan's "six stars," or experimental drug programs that the company said could be revenue drivers. In early 2017, Allergan predicted $1.5 billion to $3 billion in peak sales for abicipar, an outcome that hinged on the drug gaining approvals for diabetic macular edema and wet age-related macular degeneration.
Yet that excitement seems to have dimmed, despite forecasts that wet AMD drug sales in major markets could reach almost $19 billion by 2028. Allergan moved on from its "six stars" proposal after setbacks to several drugs. And most recently, on May 8, it came under the ownership of AbbVie, which bought the company more for marketed products than any pipeline asset.
One of the big problems abicipar ran into was competition. Patients already have effective wet AMD treatments in Regeneron's Eylea, Roche's Lucentis and off-label Avastin, which sets a high bar for new drugs to clear. Novartis, for instance, has had a tough time breaking through with its wet AMD drug Beovu due to side effects not seen with rival medicines.
Allergan has had similar problems. It showed in clinical testing that abicipar was just as effective as Lucentis. But unlike the Roche drug, abicipar led to relatively high rates of inner eye inflammation.
The company then ran another study, hoping for a cleaner safety profile. Yet the inflammation rates, while lower, were still about 9%, with a couple of patients experiencing severe side effects. The results raised doubts among Wall Street analysts, who came to expect limited use among doctors even if the drug were approved.
With an FDA rejection now in hand, the task of clearing up these safety concerns falls on AbbVie. Shares of the company were down a little more than 1% Friday morning.
"We continue to believe in the need for treatment options that provide patients with reliable vision gains and less frequent dosing for the treatment of [wet AMD]," said Michael Robinson, AbbVie's global therapeutic area head for ophthalmology, adding that the company is committed to working with the FDA on next steps.
SVB Leerink analyst Geoffrey Porges doesn't have high hopes, though. He wrote in a note to clients that, following the rejection, the likelihood of abicipar coming to market "goes from remote to impossible." The investment bank now expects AbbVie to discontinue other abicipar trials, including a mid-stage study in diabetic macular edema, and to "abandon the application and write off the development program."