Santhera Anticipates Receiving a Negative CHMP Opinion on Appeal for Marketing Authorization Application for Raxone® in Duchenne Muscular Dystrophy

Wednesday, January 24, 2018 @ 12:00 am

Liestal, Switzerland, January 24, 2018 - Santhera Pharmaceuticals (SIX: SANN) announces that on January 23 it had an oral explanation at the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in relation to the re-examination of its Marketing Authorization Application (MAA) for Raxone® (idebenone) in Duchenne muscular dystrophy (DMD). The company now anticipates that the CHMP will maintain its original position to issue a negative opinion on Santhera's MAA filed as Type II variation of its existing marketing authorization for Leber's hereditary optic neuropathy (LHON).

Santhera will provide further update on Friday, January 26, as originally announced.

You may also be interested in

Swiss Biotech Report 2024 shows sector performing well in 2023 by continuing to embrace international alliances

Record revenues of CHF 7.3 billion (USD 8.1 billion) – Capital investments increase by more than 50% to CHF 2 billion – CHF 1.4 billion by public companies, CHF 0.6 billion by private companies – Significant licensing and M&A activity in 2023 – VectivBio, T3, Vertex, Santhera – R&D investments of publicly traded biotech companies have decreased in line with global markets, wherea
April 23, 2024

SOTIO enters into agreement with Biocytogen to expand antibody-drug conjugates pipeline

Option and license agreement includes multiple fully human bispecific antibodies generated with Biocytogen’s proprietary RenLite platform Agreement will enable SOTIO to significantly broaden its next-generation ADC portfolio, including multi-specific ADCs Biocytogen will receive an upfront payment and potential development milestone payments totaling up to $325.5 million
July 16, 2024

Asceneuron secures USD 100 million financing to advance therapeutics in neurodegenerative diseases

Financing led by Novo Holdings, including new investment from EQT Life Sciences – LSP Dementia Fund, OrbiMed and SR One with participation from existing investors M Ventures, Sofinnova Partners, GSK Equities Investments Limited and Johnson & Johnson Innovation – JJDC, Inc. Funds will be used to progress lead asset ASN51, an oral small molecule OGA inhibitor, into Phase 2 clinical developme
July 16, 2024

LimmaTech appoints Staph Leavenworth Bakali as Chairman of the Board

LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, today announced the appointment of Staph Leavenworth Bakali as independent Chairman of its Board of Directors. Mr. Leavenworth Bakali brings over 30 years of senior executive and board-level experience in the life science and healthcare industries.
July 1, 2024

Newron flash update “A pivotal year” - potential of schizophrenia drug

June 27, 2024

Ymmunobio and EVIIVE: Collaboration to develop advanced liquid biopsy for cancer patients

Ymmunobio and EVIIVE are pleased to announce their strategic collaboration to develop an innovative liquid biopsy technology utilizing extracellular vesicles (EVs). This partnership marks a significant advancement in precision medicine, aiming to enhance disease detection and patient monitoring accuracy and efficacy.
June 24, 2024