Regulatory Apellis’s Syfovre becomes the first FDA-approved drug for geographic...

Apellis’s Syfovre becomes the first FDA-approved drug for geographic atrophy


According to an announcement by Apellis Pharmaceuticals, the company has just scored a second commercial nod for its C3 inhibitor pegcetacoplan for the treatment of geographic atrophy (GA), making it the first-ever drug to do so. However, it has not been approved by the agency as a cure but the approval has been granted on the basis of the drug’s ability to slow disease growth progression. 

The agency based its approval on the data collected across late-stage Derby and Oaks studies spanning 24 months. Studies proved that Apellis’s therapy lowered the rate of GA lesion growth versus a placebo and demonstrated increased treatment effects over time in multiple trials. In a release put out by the firm, it stated that the greatest benefit observed which was that of an almost 36% reduction in lesion growth was observed between the 18-24 month mark.

GA can be characterized as significant macular degeneration that is caused by old age and is also the leading cause of blindness among adults. The drug has been approved under the name of Syfovre and prior to this approval, there were no FDA-sanctioned approved therapies for geographic atrophy.

The basis for the approval of the drug is not its ability to stall or improve central vision loss, nor can it simply flip a switch and stop GA from day one. Instead, the drug should be taken as an investment that will prove to be fruitful over time. “It’s a drug where you make an investment over many years, and where the longer you stick to the therapy, the better this drug is going to work for you,” Apellis CEO Francois said.

Francois has explained that this particular characteristic of the drug where the longer you use it, the better results you get is actually a core advantage of the treatment. Not only this, but the flexible dosing regimen also gives the drug an edge. The treatment can be administered anywhere between 25 to 60 days. Most importantly, Apellis has worked to ensure that the drug works in every type of GA patient, which means that it does not matter whether the lesion in the patient’s eye is located in the center of the periphery, the drug will work equally well in slowing the lesions down in each scenario. 

Apellis has been working on launching Syfovre for the past 4 years and in preparation for this occasion has recruited around 100 field-based representatives. These range from reimbursement managers to sales and medical affairs reps. The expected date that the drug will market has been set for March when specialty distributors and pharmacies around the U.S. will make the drug available to consumers for the price of  $2,190 per vial.

Syfovre however, is not the only contender in the GA market. Roche has also been pushing its complement-inhibiting drug lampalizumab for approval but the closest threat to Apellis comes from Iveric Bio, whose C5 agent Zimura won priority review with FDA for GA the same day Apellis won its approval.

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