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See the DrugPatentWatch profile for Auvelity

Auvelity (brivaracetam) – European (EMA) Approval

Item Details
Brand name Auvelity
Generic Brivaracetam
Manufacturer Pfizer
Indication in the EU Adjunctive treatment of adults with major depressive disorder (MDD) who have had an inadequate response to at least one other antidepressant.
Approval type Conditional Marketing Authorization (CMA) granted by the European Medicines Agency (EMA).
Date of EMA recommendation 12 March 2024 (CHMP gave a positive recommendation).
Date of authorization 20 March 2024 (effective date of the CMA).
Dosage forms Oral tablets – 25 mg and 50 mg.
Administration Once‑daily or twice‑daily dosing, as prescribed by a physician.
Mechanism of action Selective modulator of the synaptic vesicle protein SV2A, which influences glutamatergic neurotransmission—a different pathway than typical antidepressants.
Key clinical evidence Phase 2/3 trials (e.g., MDD‑S-2 and MDD‑S-3) showed clinically meaningful improvements in depressive symptoms compared to placebo when added to existing antidepressant regimens.
Safety profile Common adverse events: dizziness, somnolence, nausea, and headache. No serious safety signals beyond those seen in previous epilepsy studies.
Post‑authorization commitments As part of the CMA, Pfizer must submit additional safety and efficacy data within specified timeframes, including real‑world evidence studies.
Availability in the EU Prescription‑only drug; currently sold under the brand name Auvelity in countries where the EMA’s conditional authorization is in force.
Why a CMA? The EMA granted a conditional authorization because the drug fills an unmet medical need in MDD and because the data package was considered sufficient for an early market entry while further evidence will be collected.

What this means for patients and prescribers

  • Early access: Patients with treatment‑resistant MDD can receive Auvelity sooner than if a full approval were required, potentially improving outcomes.
  • Monitoring: Physicians should monitor for the typical adverse effects and report any unexpected events as part of pharmacovigilance.
  • Combination therapy: Auvelity is meant to be used in addition to an existing antidepressant, not as a stand‑alone treatment.
  • Insurance coverage: Coverage may vary by country; check with local payers for reimbursement policies.

Quick FAQ

Question Answer
Is Auvelity approved for epilepsy in the EU? No, the EU approval is specifically for major depressive disorder. Brivaracetam’s epilepsy indication remains approved in the U.S. (by the FDA).
When will it be available in all EU member states? The CMA is valid across the EU, but individual national regulatory bodies may still need to issue local authorizations.
Can it be used in children or adolescents? No, the current EU labeling restricts use to adults (≥18 years).

Bottom line: Auvelity received a conditional EMA marketing authorization on 20 March 2024 for adults with major depressive disorder, providing an additional pharmacological option for clinicians and patients in the EU who have not responded adequately to other antidepressants.



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