Action required: Please refresh your browser
We have recently implemented some changes that require a hard refresh of your browser: Please hold down the CTRL-key and press the F5 key.
After a successful hard refresh, this message should not appear anymore.
More details about this topic are available here »
AB Science announces that CHMP adopted a negative opinion for masitinib marketing authorization in indolent systemic mastocytosis after reassessment | ||
By: Nasdaq / GlobeNewswire - 14 Sep 2017 | Back to overview list |
|
Paris, 14 September 2017, 6.30pm AB Science announces that CHMP adopted a negative opinion for masitinib marketing authorization in indolent systemic mastocytosis after reassessment AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specialized in research, development and marketing of protein kinase inhibitors (PKIs), announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has adopted a negative opinion for masitinib in the treatment of adult patients with smouldering or indolent systemic severe mastocytosis unresponsive to optimal symptomatic treatments. This decision follows the reassessment requested by AB Science after the previous negative opinion adopted by the CHMP in May 2017. The CHMP considered that there were too many uncertainties that precluded the benefit-risk assessment. These uncertainties related to i) the Good Clinical Practice (GCP) findings that were corrected too late by the Applicant, ii) the conduct of the study that excluded from the claim and the analysis the patients with either cutaneous mastocytosis or non-severe indolent systemic mastocytosis, and iii) uncertainties regarding the long-term safety profile of masitinib for a chronic condition. Overall, the CHMP considered that the product could be considered as active in the targeted indication and that the study has shown a benefit but did not provide enough robust evidence in the context of a registration based on single pivotal study. AB Science intends to initiate a confirmatory study in patients with smouldering or indolent systemic severe mastocytosis unresponsive to optimal symptomatic treatment in order to confirm the results from this first pivotal study.
About masitinib
About AB Science
Further information is available on AB Science's website: www.ab-science.com .
Forward-looking Statements - AB Science
These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents filed by AB Science with the Autorité des Marchés Financiers (AMF), including those listed in the Chapter 4 "Risk Factors" of AB Science reference document filed with the AMF on November 22, 2016, under the number R. 16-078. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations. For additional information, please contact:
AB Science
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein. Source: AB Science via GlobeNewswire
HUG#2134285
|
||
|
||
Copyright 2017 Nasdaq / GlobeNewswire | Back to overview list |