US FDA seeks more information on Maxigesic IV® application
01 Luglio 2022 - 09:55AM
GlobeNewswire Inc.
US FDA seeks more information on Maxigesic IV® application
US FDA seeks more information on
Maxigesic IV® application
For Immediate release
Liège, Belgium – 01 July 2022 - Regulted
information - Inside Information - Hyloris Pharmaceuticals SA
(Euronext Brussels : HYL) announces that it has today
received a Complete Response Letter (CRL) from the US Food and Drug
Administration (FDA) on its application for the US registration of
Maxigesic IV®. The FDA has only requested additional data on one
remaining topic.
“We believe, along with our partners at AFT,
that generating the additional information that FDA requires to
support the NDA submission of Maxigesic IV® will allow the product
to fulfill its full commercial potential in the US and not affect
the Company’s other existing development programs. The additional
work required by FDA falls well within the parameters of our normal
operational budget and will be completed expeditiously said
Stijn Van Rompay, Chief Executive Officer of
Hyloris.”
Maxigesic® IV, is a novel, unique combination of 1000mg
paracetamol and 300mg ibuprofen solution for infusion, for the
treatment of post-operative pain and is currently licensed in more
than 100 countries across the globe. It has also been registered in
39 countries and launched in 7 countries including Australia,
Germany and Korea. The medicine is protected by several granted
patents and pending patent applications.
About Hyloris Pharmaceuticals Hyloris is a
specialty biopharma company focused on innovating, reinventing, and
optimizing existing medications to address important healthcare
needs and deliver relevant improvements for patients, healthcare
professionals and payors. Hyloris has built a broad, patented
portfolio of 14 reformulated and repurposed value-added medicines
that have the potential to offer significant advantages over
available alternatives. Outside of its core strategic focus, the
Company also has 4 high barrier generic products in development and
registration phase. Two products are currently in initial phases of
commercialisation with partners: Sotalol IV for the treatment of
atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative
pain treatment. The Company’s development strategy primarily
focuses on the FDA’s 505(b)2 regulatory pathway, which is
specifically designed for pharmaceuticals for which safety and
efficacy of the molecule have already been established. This
pathway can reduce the clinical burden required to bring a product
to market, and significantly shorten the development timelines and
reduce costs and risks. Hyloris is based in Liège, Belgium. For
more information, visit www.hyloris.com and follow-us
on LinkedIn.
For more information contact :
Hyloris Pharmaceuticals, Investors and Media
investorrelations@hyloris.com Disclaimer
and forward-looking statements Hyloris means “high yield,
lower risk”, which relates to the 505(b)(2) regulatory pathway for
product approval on which the Issuer focuses, but in no way relates
or applies to an investment in the Shares. Certain statements in
this press release are “forward-looking statements.” These
forward-looking statements can be identified using forward-looking
terminology, including the words "believes", "estimates,"
"anticipates", "expects", "intends", "may", "will", "plans",
"continue", "ongoing", "potential", "predict", "project", "target",
"seek" or "should", and include statements the Company makes
concerning the intended results of its strategy. These statements
relate to future events or the Company’s future financial
performance and involve known and unknown risks, uncertainties, and
other factors, many of which are beyond the Company’s control, that
may cause the actual results, levels of activity, performance or
achievements of the Company or its industry to be materially
different from those expressed or implied by any forward-looking
statements. The Company undertakes no obligation to publicly update
or revise forward-looking statements, except as may be required by
law.
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