Orchard Therapeutics Announces Swissmedic Validation of the Marketing Authorization Application for Libmeldy (atidarsagene autotemcel)
BOSTON and LONDON, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced its marketing authorization application (MAA) for Libmeldy® (atidarsagene autotemcel) has been accepted for evaluation by the Swiss Agency for Therapeutic Products (Swissmedic) for the potential treatment of eligible patients with early-onset metachromatic leukodystrophy (MLD). The Swiss filing was based on the European Union (EU) MAA for Libmeldy, which was approved by the European Commission in December 2020. Libmeldy is registered in the EU, Iceland, Liechtenstein, Norway and the United Kingdom (UK). The company expects to receive Swissmedic’s assessment report in the first half of 2023.
“Swissmedic’s validation of the MAA is a key component of our commercial expansion efforts in Europe to secure additional approvals in countries and territories where Libmeldy is not currently authorized,” said Braden Parker, chief commercial officer of Orchard Therapeutics. “We are encouraged by our continued dialogue with regulatory authorities on the safety and efficacy of this important therapy for eligible children with early-onset MLD, including the long-term clinical outcomes seen in clinical trials.”
About Libmeldy / OTL-200
The most common adverse reaction attributed to treatment with Libmeldy was the occurrence of anti-ARSA antibodies. In addition to the risks associated with the gene therapy, treatment with Libmeldy is preceded by other medical interventions, namely bone marrow harvest or peripheral blood mobilization and apheresis, followed by myeloablative conditioning, which carry their own risks. During the clinical studies, the safety profiles of these interventions were consistent with their known safety and tolerability.
For more information about Libmeldy, please see the Summary of Product Characteristics (SmPC) available on the EMA website.
Libmeldy is approved in the European Union, UK, Iceland, Liechtenstein and Norway. OTL-200 is an investigational therapy in the U.S.
Libmeldy was developed in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy.
About Orchard Therapeutics
In 2018, the company acquired GSK’s rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Today, Orchard is advancing a pipeline spanning pre-clinical, clinical and commercial stage HSC gene therapies designed to address serious diseases where the burden is immense for patients, families and society and current treatment options are limited or do not exist.
Availability of Other Information About Orchard
Other risks and uncertainties faced by Orchard include those identified under the heading "Risk Factors" in Orchard’s most recent annual or quarterly report filed with the U.S. Securities and Exchange Commission (SEC), as well as subsequent filings and reports filed with the SEC. The forward-looking statements contained in this press release reflect Orchard’s views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Contacts Investors Renee Leck Senior Director, Investor Relations +1 862-242-0764 [email protected] Media Benjamin Navon Director, Corporate Communications +1 857-248-9454 [email protected]
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