SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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|Item 8.01|| |
Tecfidera CHMP Update
On November 18, 2021, Biogen received an Opinion adopted by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) at its November meeting on the ad hoc assessment relating to the therapeutic effect of monoethyl fumarate salts (MEF) within Fumaderm for the purpose of implementation of the May 5, 2021 Judgment of the General Court (Case T-611/18) annulling the EMA’s non-validation decision for a generic application of Tecfidera and in connection with a number of pending applications before the CHMP which concern dimethyl fumarate. The Company, the EMA, and the European Commission have each appealed the General Court’s decision as wrongly decided.
The CHMP Opinion states:
The CHMP, having considered the matter as set out in the appended ad hoc assessment report, is of the opinion that taking into account the described results, including the severe methodological limitations of the clinical studies, it cannot be concluded based on these data that a clinically relevant therapeutic effect of MEF in Fumaderm has been demonstrated.
Therefore, the CHMP concludes that the totality of the available data cannot establish that MEF exerts a clinically relevant therapeutic contribution within Fumaderm.
|Item 9.01|| |
Financial Statements and Exhibits.
The exhibits listed below are furnished as part of this Current Report on Form 8-K
|Cover Page Interactive Data File (embedded within the Inline XBRL document)|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Chief Corporation Counsel and Assistant Secretary|
Date: November 19, 2021