AB Science announces that Health Canada has resumed its review of the New Drug Submission for masitinib in amyotrophic lateral sclerosis, following issuance of a screening acceptance letter
09 Mai 2023 - 6:06PM
AB Science announces that Health Canada has resumed its review of
the New Drug Submission for masitinib in amyotrophic lateral
sclerosis, following issuance of a screening acceptance letter
PRESS RELEASE
AB SCIENCE ANNOUNCES
THAT HEALTH CANADA
HAS RESUMED ITS
REVIEW OF THE NEW
DRUG SUBMISSION FOR
MASITINIB IN AMYOTROPHIC LATERAL
SCLEROSIS, FOLLOWING ISSUANCE OF A SCREENING
ACCEPTANCE LETTER
Paris, 09 May, 2023, 6pm CET
AB Science SA (Euronext -
FR0010557264 - AB) today announces that Health Canada has issued a
screening acceptance letter for the application of masitinib in the
treatment of amyotrophic lateral sclerosis (ALS), meaning that the
information and materials submitted by AB Science in response to
the Notice of Deficiency (NOD) previously issued by Health Canada
have been screened and found acceptable for the New Drug Submission
to resume.
This letter is an important step in the
procedure and effectively marks the restart date of the
application’s review by Health Canada. Indeed, once the Response to
a NOD is screened and found acceptable for scientific review, a new
review period begins immediately.
Under the NOC/c policy, Health Canada has a
target of 200 calendar days maximum to review the application.
As a reminder, Health Canada issued in December
2022 a notice of deficiency (NOD) for the New Drug Submission of
masitinib in the treatment of amyotrophic lateral sclerosis,
meaning that Health Canada requested the provision of additional
information. AB Science submitted its revised application in April
2023, which has now been found acceptable for scientific
review.
The application includes new analysis, recently
presented at the American Academy of Neurology (AAN) 2023 Annual
Meeting in Boston, performed in ALS patients prior to any complete
loss of physical function (corresponding to a score of 0 on any
ALSFRS-R individual component and regardless of baseline
progression rate and accounting for about 80% of the overall
AB10015 study population), showing a statistically significant
18.4% relative benefit on the CAFS endpoint in favor of masitinib
4.5 mg/kg/day as compared with control (p=0.035). The composite
endpoint of functioning and survival (CAFS) is recommended by FDA
and Health Canada as a primary endpoint to evaluate efficacy in ALS
trials.
Alain Moussy, co-founder and CEO of AB Science,
said: “There is an urgent need expressed by ALS patients and their
families in Canada to access masitinib treatment under NOC/c status
and we will continue to work diligently with Health Canada to
respond to this need.”
An estimated 3,000 Canadians are currently
living with ALS. Each year approximately 1,000 Canadians die from
ALS. A similar number of Canadians are diagnosed with ALS each
year.
About AB ScienceFounded in
2001, AB Science is a pharmaceutical company specializing in the
research, development and commercialization of protein kinase
inhibitors (PKIs), a class of targeted proteins whose action are
key in signaling pathways within cells. Our programs target only
diseases with high unmet medical needs, often lethal with short
term survival or rare or refractory to previous line of treatment.
AB Science has developed a proprietary portfolio of molecules and
the Company’s lead compound, masitinib, has already been registered
for veterinary medicine and is developed in human medicine in
oncology, neurological diseases, inflammatory diseases and viral
diseases. The company is headquartered in Paris, France, and listed
on Euronext Paris (ticker: AB).
Further information is available on AB Science’s
website: www.ab-science.com.
Forward-looking Statements - AB
ScienceThis 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, future services, product development
and their potential or future performance.
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 published by AB Science. 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 ScienceFinancial
Communication & Media Relations investors@ab-science.com
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