Pyros Pharmaceuticals Announces Positive Outcome of the European Decentralised Procedure for Approval of VIGZIP™ (vigabatrin oral solution)

PARSIPPANY, N.J.--(BUSINESS WIRE)-- Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced today the positive outcome of the Decentralised Procedure (DCP) for VIGZIP™ (vigabatrin oral solution) in Europe. This significant milestone follows the issuance of the Final Assessment Report from the Reference Member State (RMS), the German Federal Institute for Drugs and Medical Devices (BfArM), and the agreement of all four E.U. Concerned Member States (CMS) in DCP that VIGZIP™ is approvable.

The regulatory process will now transition into the national phase of the DCP. During this phase, the RMS Germany and each of the CMS will grant a national marketing license, enabling VIGZIP™ to be marketed in each country.

VIGZIP™ will be indicated for monotherapy in the treatment of infantile spasms (West’s syndrome), as well as treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy with or without secondary generalization, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.

“We are incredibly pleased with the positive outcome supporting the approval of VIGZIP™ in several key European markets. This achievement serves as a testament to our dedication to developing innovative solutions for unmet medical needs in rare pediatric diseases. Pyros remains committed to expanding access to VIGZIP™ in other additional territories around the world,” stated Michael Smith, Chief Executive Officer of Pyros.

About Pyros

Pyros Pharmaceuticals is developing enhanced specialty pharmaceuticals for rare diseases. Our mission is to elevate the standard of care for infantile spasms, providing treatment options that significantly improve the lives of affected children. Through our enhanced therapies and comprehensive support services, we aim to assist providers and caregivers in navigating the complexities of the patient journey.

For more information, please visit: www.pyrospharma.com

Forward-Looking Statements

The Company has made statements throughout this press release which constitute forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that may cause its actual results, levels of activity, performance or achievements to be materially different from any results, levels of activity, performance or achievements expressed or implied by any such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expect,” “hopes,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “likely,” “potential,” or “continue” or the negative of these terms and similar words. Although management believe that the expectations reflected in these forward-looking statements are reasonable, management cannot guarantee future results, levels of activity, performance or achievements. Furthermore, management undertakes no obligation to update any forward-looking statements for any reason unless required to do so by law.

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