European Commission approval of Ztalmy® (ganaxolone) for the adjunctive treatment of epileptic seizures associated with CDKL5 deficiency disorder

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The European Commission has granted marketing authorisation in the European Union (EU) for Ztalmy® (ganaxolone) oral suspension for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age.

Metadata

Provider:

GlobeNewswire, Inc.

Retrieved on:

Monday, July 31, 2023

Information

Tags:

Orion, Ganaxolone, Seizure, CDD, CDKL5 deficiency disorder, Genetic disorder, Civil service commission, Patient, CDKL5, European Commission, European, Pharmaceutical industry, EU

Geotags:

ESPOO, FI, EUROPEAN UNION, EUROPE

⚠ partially generated by AI ↴

Organisation:

ORION, ORION OYJ, ZTALMY, MARINUS PHARMACEUTICALS

Summary

Key Points:

The European Commission has granted marketing authorisation in the European Union (EU) for Ztalmy® (ganaxolone) oral suspension for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age.
ZTALMY may be continued in patients 18 years of age and older.
Ganaxolone is developed by Marinus Pharmaceuticals, Inc. and under a collaboration agreement Orion has the right to sell and market ZTALMY in Europe.
Following the European Commission approval, Orion is focusing on making ZTALMY available for patients in Europe and has pricing and reimbursement processes planned or underway in Europe.

ORION CORPORATION
PRESS RELEASE
31 July 2023 at 14.00 EEST

European Commission approval of Ztalmy® (ganaxolone) for the adjunctive treatment of epileptic seizures associated with CDKL5 deficiency disorder

The European Commission has granted marketing authorisation in the European Union (EU) for Ztalmy^® (ganaxolone) oral suspension for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age. ZTALMY may be continued in patients 18 years of age and older. CDD is a serious and rare genetic disorder.

Ganaxolone is developed by Marinus Pharmaceuticals, Inc. and under a collaboration agreement Orion has the right to sell and market ZTALMY in Europe. Following the European Commission approval, Orion is focusing on making ZTALMY available for patients in Europe and has pricing and reimbursement processes planned or underway in Europe.

About ZTALMY^®
ZTALMY (ganaxolone) is a neuroactive steroid GABA_A receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects. ZTALMY is an oral prescription medicine approved by the European Commission for the adjunctive treatment of epileptic seizures associated with CDKL5 deficiency disorder in patients two to 17 years of age. ZTALMY may be continued in patients 18 years of age and older.

About Marinus Pharmaceuticals
Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The Company first introduced FDA-approved prescription medication ZTALMY^® (ganaxolone) oral suspension in the U.S. in 2022 and continues to invest in the potential of ganaxolone in IV and oral formulations to maximize therapeutic reach for adult and pediatric patients in acute and chronic care settings. For more information about Marinus visit www.marinuspharma.com.

Full European Summary of Product Characteristics for ZTALMY is available from the EMA website at www.ema.europa.eu/en.

Additional information:

Camilla Steinby, Head of Global Pain Business Unit
Orion Corporation
[email protected]
tel. +358 50 966 7823

Contact person for the media:
Terhi Ormio, Vice President, Communications
Orion Corporation
[email protected]
tel. +358 50 966 4646

Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
www.orion.fi

Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and self-care products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. Orion's net sales in 2022 amounted to EUR 1,341 million and the company had about 3,500 employees at the end of the year. Orion's A and B shares are listed on Nasdaq Helsinki.