REPRESENTATION
AB SCIENCE PROVIDES UPDATE ON APPLICATION FOR CONDITIONAL MARKETING AUTHORIZATION OF MASITINIB IN AMYOTROPHIC LATERAL SCLEROSIS
Paris, 17 October 2024, 7.30pm CET
AB Science SA (Euronext – FR0010557264 – AB) today announces that the European Medicines Agency (EMA) confirmed a negative opinion for the conditional marketing authorization of masitinib in the treatment of amyotrophic lateral sclerosis (ALS), following a vote taken to the Committee for Medicinal Products for Human Use (CHMP) meeting on 14-17 October 2024. The Conditional Marketing Authority for masitinib had been under review by the CHMP in response to the company’s request for a review of the negative opinion published in June 2024.
Despite the difficulty of unconditional marketing authorization in ALS, AB KNOWLEDGE requested a review first and importantly considering the urgent need for patients to have early access to a promising treatment and the clinical data obtained from the first AB10015 study, showing an increase in overall median survival of + 6 months (p = 0.0761 ) in the primary analysis population of normal progressors, and a survival advantage + 12 months significant (p = 0.0192) in a subgroup defined as patients before they lost function total (ie without a patient with an ALSFRS-R score of 0 in any of the 12 items of the scale).
A Scientific Advisory Group – Neurology (SAG-N) was provided for the first time, as part of the review process. Importantly, the SAG-N experts agreed with the classification method to differentiate between Normal and Fast Progressors (and with the 1.1 points per month ALSFRS declining from the beginning as a cut-off), if specified in advance. This observation supports the design of the validation study of masitinib in ALS, since the same dichotomization and the same cut-off are pre-specified for the validation study.
The phase 2B/3 study AB10015 is considered hypothesis generating but insufficient as a single primary study to support marketing authorization.
Separately, Health Canada recently notified AB Science that key analyzes were presented for the review submitted in May 2024 [1]considered new data, rather than a review of existing data. As Health Canada guidelines prohibit the use of new data as part of the review process, AB Science has decided to notify Health Canada that they will not proceed with the review. Health Canada has provided an opportunity to submit a new application to resolve this matter.
Alain Moussy, CEO and co-founder of AB Science, said:We are grateful to the patients and physicians who supported the review process as part of the EMA study. We made all these efforts for the patients. We are convinced that masitinib is a promising drug when we see patients from the study surviving the drugs for more than 10 years in our compassionate use program. Now AB Science’s goal is to focus on the phase 3 validation program of masitinib in ALS to reach full approval“.
References
[1] AB Science press release dated 3 April 2024
About AB Science
Founded in 2001, AB Science is a pharmaceutical company that specializes in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins that play a vital role in to identify pathways within cells. Our programs focus only on diseases with high unmet medical needs, often fatal with short or rare survival or unresponsive to the previous line of treatment.
AB Science has developed a proprietary portfolio of molecules and the Company’s lead compound, masitinib, is already registered for veterinary medicine and is being developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and is listed on Euronext Paris (ticker: AB).
More information is available on the AB Science website:
www.ab-science.com.
Forward Statements – AB Science
This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, services in the period future, product development and their future potential or performance.
These forward-looking statements are often identified by the words “anticipate”, “anticipate”, “believe”, “anticipate”, “estimate” or “plan” as well as other similar terms. Although AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to a number of risks and uncertainties that are difficult to predict and in generally beyond AB Science’s control and may imply that results and events are real. materially different from those expressed, implied or anticipated in the information and forward-looking statements. These risks and uncertainties include uncertainties related to the Company’s product development that may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect the marketability of the products developed by AB Science, as well. as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or commitment to update the information and forward-looking statements, subject to the relevant regulations, in particular articles 223-1 et seq. AMF General Rules.
For more information, please contact:
AB Science
Financial Communications & Media Relations
[email protected]
2024-10-17 17:36:00
#Science #update #application #unconditional #marketing #authorization #masitinib #ALS
