Apellis Announces Pegcetacoplan MAA Review Has Been Reset to Day 180 of Initial Assessment by European Medicines Agency (EMA)

Rhea-AI Summary

Apellis Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has reset the review of the marketing authorization application for intravitreal pegcetacoplan, following a recent judgment by the Court of Justice of the European Union. The decision by EMA is procedural and not related to the pegcetacoplan data package. An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected no later than July 2024.

• Decision by EMA follows recent judgment by the Court of Justice of the European Union regarding the organization of EMA’s expert groups
  
• Apellis anticipates a CHMP opinion no later than July 2024
  

WALTHAM, Mass., April 26, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the European Medicines Agency (EMA) has reset the review of the marketing authorization application (MAA) for intravitreal pegcetacoplan for geographic atrophy to the last phase of the initial assessment (day 180). The procedure is expected to be led by the original rapporteurs, and EMA has stated their intent to convene a new expert group meeting. Apellis anticipates an opinion from the Committee for Medicinal Products for Human Use (CHMP) no later than July 2024.

The update follows the judgment by the Court of Justice of the European Union (CJEU) on March 14, 2024, which ruled on the organization of EMA’s expert groups. The judgment has implications on EMA's policy for handling competing interests of experts.

This decision by EMA is strictly procedural in response to the CJEU judgment and is not related to the pegcetacoplan data package. Apellis will continue to work closely with EMA on the review of the pegcetacoplan marketing application.

About Apellis
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. We believe we have only begun to unlock the potential of targeting C3 across serious retinal, rare, and neurological diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn.

Apellis Forward-Looking Statement
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether pegcetacoplan will receive approval from foreign regulatory agencies for GA when expected or at all, including the impact on the likelihood and timing of such approvals; and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 27, 2024 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Media Contact:
Lissa Pavluk
media@apellis.com
617.977.6764

Investor Contact:
Meredith Kaya
meredith.kaya@apellis.com
617.599.8178

FAQ

When was the review of the marketing authorization application for intravitreal pegcetacoplan reset by the EMA?

The review was reset to day 180 of the initial assessment.

What is the expected timeline for an opinion from the CHMP?

An opinion from the CHMP is anticipated no later than July 2024.

What recent judgment influenced the EMA's decision to reset the review?

The recent judgment by the Court of Justice of the European Union regarding the organization of EMA’s expert groups influenced the decision.

Is the EMA's decision related to the pegcetacoplan data package?

No, the decision by EMA is strictly procedural and not related to the pegcetacoplan data package.

How will Apellis proceed following the EMA's decision?

Apellis will continue to work closely with EMA on the review of the pegcetacoplan marketing application.