Roche scores FDA nod for prefilled syringe version of Vabysmo, easing its administration

08 Jul 2024
www.fiercepharma.com
Drug Approval
Roche scores FDA nod for prefilled syringe version of Vabysmo, easing its administration
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Source: FiercePharma
The FDA has signed off on Roche's Vabysmo to be distributed by way of a prefilled syringe, which provides a convenient option for retina specialists who administer the blockbuster drug.
Since Roche gained approval for its eye disease medication Vabysmo in 2022, it has stormed a market dominated by Regeneron and Bayer’s Eylea.
Friday, Roche took another step in its advancement of the blockbuster medicine, scoring an FDA nod to provide it in a prefilled syringe. The 6-mg, single-dose shot will give doctors a simplified, ready-to-use alternative to extracting Vabysmo from a vial.
Vabysmo PFS will be available later this year—along with its current 6-mg vial product—for the treatment’s three indications. The FDA endorsed Vabysmo for wet-age macular degeneration and diabetic macular edema in January 2022 and followed with a nod for retinal vein occlusion nine months ago.
“While many retina specialists are already using Vabysmo as a first-line treatment, this new offering should make it even simpler to administer, thereby enhancing the treatment experience for both physicians and patients,” Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development for Roche subsidiary Genentech, said in a release.
In addition to the convenience provided by the elimination of steps, a prefilled syringe can reduce potential contamination and dosing errors. Storage and disposal also is easier as fewer materials are needed to administer the drug.
Nearly 3 million people in the U.S. are affected by one of the three diseases Vabysmo treats, each of which can cause blindness. Roche said more than 4 million doses of Vabysmo have been distributed around the world in the 95 countries in which it is approved.
When Vabysmo hit the market as the only bispecific antibody treatment for the eye, its major advantage was its dosing regimen, which could extend up to once every four months compared to every two months for Eylea. Regeneron and Bayer answered in August of last year, winning FDA approval for their high-dose version of Eylea, which can extend dosing intervals beyond four months for some patients.
In the first quarter of 2024, Vabysmo accounted for sales of 847 million Swiss francs ($933 million), a 108% increase year over year. Meanwhile, Regeneron reported that sales of the Eylea franchise were down 2% in the U.S. to $1.4 billion, with Eylea HD accounting for $200 million.
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