NANJING, China, Sept. 14,
2024 /PRNewswire/ -- On September
2, 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK)
announced that Sanbexin Sublingual Tablets (Edaravone and
Dexborneol sublingual tablets), an innovative drug for stroke, has
been granted the Breakthrough Therapy designation by the U.S. Food
and Drug Administration (FDA) for the treatment of Acute Ischemic
Stroke (AIS). Sanbexin sublingual tablets is the first innovative
drug in the world to be designated with the Breakthrough Therapy by
the FDA for the treatment of stroke.
The Breakthrough Therapy designation stems from the provisions
of 《Food and Drug Administration Safety and Innovation Act》. It is
designed to expedite the development and regulatory review of drugs
for treating serious diseases and addressing significant unmet
medical needs. The designation will be beneficial for the drugs to
obtain the FDA's guidance in the clinical development, accelerate
the overseas clinical development process, and is also expected to
significantly shorten the time for marketing review through the
priority review designation.
The Breakthrough Therapy designation is based on the significant
improvement in efficacy metrics demonstrated by the sublingual
tablets in a previous clinical study. The data from a multicenter,
randomized, double-blind, parallel, placebo-controlled Phase III
clinical study in China for the
treatment of AIS demonstrated that Sanbexin sublingual tablets
significantly improved neurological recovery and independent living
ability in patients with AIS compared to placebo, meeting the
expected efficacy endpoints with a favorable safety profile. JAMA
Neurology published the study's key findings online.
The designation will be beneficial for Simcere to obtain the
FDA's guidance in the clinical development of Sanbexin sublingual
tablets, accelerate the overseas clinical development process, and
is also expected to significantly shorten the time for marketing
review through the priority review designation.
According to a recent article in The Lancet, stroke is the
second leading cause of death and disability worldwide, with 12
million new cases and 6.6 million deaths each year. Among them,
acute ischemic stroke is the most common type of stroke, accounting
for about 70% of all strokes, and constituting a heavy disease
burden for all countries around the world. The efficacy of acute
ischemic stroke treatment is highly time-dependent. Receiving
treatment as early as possible will help patients to improve their
disease outcome and avoid disability.
Sanbexin sublingual tablets is a brain cytoprotective agent
composed of edaravone and dexborneol, two active ingredients with
synergistic anti-oxidant and anti-inflammatory effects, which can
significantly reduce brain cell injury or impairment caused by AIS.
Such unique sublingual formulation can quickly disintegrate once in
contact with the saliva once place under the tongue and can be
absorbed into the blood through the sublingual venous plexus, which
is expected to increase the flexibility of stroke treatment.
Sequential therapy consisting of the marketed Sanbexin concentrated
solution for Injection. These two formulae enable patients to
receive a complete course of treatment in and outside of the
hospital.
On June 28, 2023, the new drug
application (NDA) for Sanbexin sublingual tablets in China is accepted by the National Medical
Products Administration. The first indication is for the
improvement of neurological symptoms, daily activities, and
functional impairment due to AIS. Phase I clinical trials for
Sanbexin sublingual tablets on healthy volunteers have been
completed in the United
States.
CONTACT: Haoyun Huang, huanghaoyun@simcere.com
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