Apellis Pharmaceuticals, a global biopharmaceutical company has announced that it has received the US Food and Drug Administration’s (FDA) approval of SYFOVRE™ (pegcetacoplan injection) 15mg/0.1mL injection, the first and only treatment for geographic atrophy (GA) secondary to age-related macular degeneration. This means that starting now, people living with GA in the USA have access to treatment. For far too long, those living with GA have been without options, and this approval brings new hope for those affected by the disease. The press release of the announcement can be found here.
“The FDA’s recent approval of SYFOVRE™ represents a significant advancement for the retina community, particularly for those affected by GA, who now have a treatment option available to them for the first time. As we shift our focus to the global community, we eagerly anticipate further regulatory decisions on SYFOVRE™ in other regions. We understand the critical need for GA treatments worldwide and remain dedicated to ongoing efforts to ensure equitable and timely access to diagnosis and treatment for those affected by the disease.” says Avril Daly, CEO of Retina International.
The lay summaries of the two pivotal studies that are relevant to this release can be found at the bottom of this document.
Some of the questions and their answers that could be of relevant to our membership community are as follows: (Please note that this information was provided by Apellis Pharmaceuticals.)
Q: Is pegcetacoplan available in my country (outside of the U.S.)? If not, when would I be able to get this medicine in my country?
A: SYFOVRE™ is only approved in the U.S. We submitted our Marketing Authorization Application to European Medicines agency in late 2022. We anticipate a decision from the European Medicines Agency in early 2024. We will provide updates on our progress in other regions as available.
Q: When will there be approval from the European Medicines Agency (or other country-specific regulatory agencies outside of the U.S.)?
A: We submitted our Marketing Authorization Application to European Medicines agency in late 2022. We anticipate a decision from the European Medicines Agency in early 2024. We will provide updates on our progress in other regions as available.
Q: If the medicine is available in the U.S. (and the person asking lives outside the U.S.)
Can I go to the U.S. to get the medicine and bring back to my country?
A: We encourage you to talk with your doctor.
Can I receive the injection in the U.S.?
A: We encourage you to talk with your doctor.
Q: How can I find a doctor who could get this medicine for me in my country (outside of the U.S.)?
A: We are unable to recommend a specific doctor and encourage you to do your own research.
Q: Where can I find more information about this medicine?
A: For more information on SYFOVRE™ – please refer to the U.S. Prescribing (PI) Information – LINK to USPI.
Lay summaries of the DERBY and OAKS study are presented below: