-
EMEA Grants New Active Substance (NAS) Status for Fampridine-SR
-
Small and Medium Enterprise (SME) Status Granted to Acorda
-
Ex-U.S. Partnership Discussions Ongoing
Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced that, in response to its eligibility application to the
European Medicines Agency (EMEA) for Fampridine-SR, the EMEA has
notified the Company that Fampridine-SR is eligible to be submitted for
a Marketing Authorization Application (MAA) via the Agency’s Centralized
Procedure. The Centralized Procedure provides for a single, coordinated
review that is conducted by the EMEA on behalf of all European Union
(EU) member states.
The EMEA also designated Fampridine-SR as a New Active Substance (NAS);
if approved, compounds designated as an NAS receive a 10-year market
exclusivity period in EU member states.
Ron Cohen, M.D., President and CEO of Acorda, noted: “Fampridine-SR
potentially represents a novel and important therapeutic option for
people with MS who have walking impairment. This confirmation by EMEA of
Fampridine-SR’s eligibility for a centralized MAA filing and its
granting of NAS status are key steps in the process toward making
Fampridine-SR available to patients in the EU who may benefit from it.
We are advancing the European regulatory process as we continue our
discussions with potential ex-U.S. marketing partners. Should these
discussions result in a partnership, we plan to time the filing of the
MAA to allow our partner to provide input before submission.”
The EMEA additionally granted Acorda Small and Medium Enterprise (SME)
status. The SME program is an EMEA initiative to assist small companies
applying for approval of medicinal products. By being designated an SME,
companies are eligible for elimination or reduction of certain fees,
have access to scientific advice during the clinical development and
application processes, and EMEA assumes responsibility for certain
required translations as long as they stay under the 250 employee limit.
The U.S. Food and Drug Administration (FDA) is currently reviewing a New
Drug Application (NDA) for Fampridine-SR.
