- The Food and Drug Administration on Friday approved two medicines from Regeneron Pharmaceuticals, clearing one for a common form of vision loss and the other for an ultra-rare hereditary disease.
- The agency greenlighted a high-dose version of Eylea, Regeneron’s top-selling medicine, for patients with age-related macular degeneration, diabetic macular edema or diabetic retinopathy. The new version is meant to be as potent and safe as the original, but require less frequent injections.
- The regulator also approved Veopoz, a drug Regeneron developed for adults or young children with a life-threatening immune disorder known as Chaple disease. The condition is extremely uncommon, with fewer than 10 patients identified in the U.S. Regeneron is evaluating its “broader potential” in other diseases, Chief Scientific Officer George Yancopoulos said in a statement.
The back-to-back approvals complete a quicker turnaround for Regeneron than Wall Street analysts expected when high-dose Eylea was rejected in June.
The FDA had turned back Regeneron’s application because of a manufacturing issue at a contractor’s facility used to fill vials of the medication. Analysts feared a lengthy delay, as other companies in similar situations have needed as many as nine months to resolve such problems.
A delay of that length would have been a problem for Regeneron. A rival drug from Roche, Vabysmo, has been gaining ground on Eylea, which has long dominated the market for age-related macular degeneration treatment and accounts for most of Regeneron’s revenue. Biosimilar competitors are looming too, with the first expected to launch next year.
Yet on a conference call earlier this month, executives said the FDA was working “expeditiously” to resolve the issue. They also indicated the reviews of high-dose Eylea and Veopoz were linked, as both drugs share the same manufacturing line.
Now the company will see whether its newer drug can better stave off competition. While Eylea is administered once every two months for AMD, the high-dose form can be given less frequently after an initial regimen. AMD or DME patients can go two to four months between shots, while diabetic retinopathy patients can get a two- to three-month break.
Regeneron priced the new version at $2,625 per vial, according to a statement from the company. That’s more than Eylea’s $1,850 price tag, as well as Vabysmo’s $2,190 per vial cost. However, according to Regeneron’s statement, the new version’s yearly price is expected to be “in the range of, or lower than” that of Eylea and varies depending on factors like a patient’s prescribed dosing schedule.
“Getting this off the ground while competitive erosion from Vabysmo is still relatively modest is a win, though much still needs to break right” for Regeneron “to hold on to maximal share,” wrote RBC Capital Markets analyst Brian Abrahams in a client note.
For example, it’s not clear how fast doctors will adopt the new drug before biosimilars arrive or whether clinicians will switch patients whose disease is already controlled by standard Eylea, Abrahams wrote.
Citing surveys of retinal specialists, Piper Sandler analyst Christopher Raymond estimated in a recent note that the Eylea franchise will generate between $6 billion to $7 billion in annual U.S. revenue between 2023 and 2025. U.S. sales totaled about $6.3 billion last year.
Meanwhile, the approval for Veopoz is the first step in a broader development program. Regeneron is testing the drug alongside an Alnylam Pharmaceuticals medicine in people with myasthenia gravis and paroxysmal nocturnal hemoglobinuria, two immune disorders that have drawn the interest of several drugmakers.
Initial results from a Phase 3 study in the latter condition are expected next year, according to a federal clinical trials database.
Regeneron will charge $34,615.38 per vial of Veopoz at list price, according to a Regeneron spokesperson.