For Apellis Pharmaceuticals, the emergence of rare but serious side effects has cast a pall over the launch of the company’s geographic atrophy med Syfovre. Since the side effects were reported earlier this month, however, Apellis has been putting its nose to the grindstone seeking to get to the bottom of the safety issue.
Now, the company is coming forward with initial findings—plus an earnings report—all while bolstering its case for Syfovre with a clutch of long-term data.
While touting the “strong commercial execution” of Syfovre’s launch, Apellis’ CEO Cedric Francois, M.D., Ph.D., admitted the company has become aware of several cases of retinal vasculitis tied to the drug’s use. Following those “rare events,” Apellis kicked off a “comprehensive investigation into the potential cause of these events,” Francois said in a statement.
Apellis has found “no indication of drug product or manufacturing issues," the company stressed.
In mid-July, the American Society of Retinal Specialists (ASRS) issued a letter to doctors flagging cases of eye inflammation in patients who received Syfovre. The condition is a type of inflammation that blocks blood flow to the retina and can potentially cause blindness.
ASRS didn’t link the safety issues to any specific batches of the product. The organization noted that the side effect took hold one to two weeks after the patients' first Syfovre injection.
Now, Apellis says it has confirmed seven total events of non-occlusive or occlusive retinal vasculitis since launch. Additionally, Apellis is investigating a possible eighth case.
The company notes that it has distributed more than 68,000 Syfovre vials so far. In addition, providers have performed more than 23,000 injections in clinical trials.
Apellis says its review found no manufacturing issues affecting product quality. There’s no indication of drug-related immunogenicity based on clinical trial data, either, Apellis added.
While Apellis continues to probe the safety issue, the company has also dropped some promising data on its med from a long-term extension study.
In the phase 3 Gale trial, which followed 30 months of continuous treatment with Syfovre, the drug cut nonsubfoveal geographic atrophy lesion growth by up to 45% between the 24th and 30th months of treatment versus placebo.
The ups and downs for Syfovre have come early in the launch for Apellis, which clinched a world-first geographic atrophy nod for its med pegcetacoplan in February.
For the second quarter of 2023, Apellis reeled in total U.S. product sales of $89.6 million. More than $67 million came from Syfovre, versus $22.3 million for Empaveli, which shares the active ingredient pegcetacoplan and is approved in paroxysmal nocturnal hemoglobinuria (PNH).
All told, Apellis’ total revenues from the quarter came in at $95 million. That’s a big increase from the $16.3 million Apellis’ brought home over the same period in 2022.