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Source: Guanlan Pharmaceutical
On November 10th, Suzhou Aozong Biotechnology Co.
, Ltd.
(hereinafter referred to as "Aozong Bio") announced that the US FDA has granted its new drug TTYP01 orphan drug designation for the treatment of amyotrophic lateral sclerosis (ALS).
.
TTYP01 tablet is an oral preparation of edaravone developed by Aozong Biology for many years, and it is a 505b2 improved new drug
TTYP01 tablets are based on the safety and effectiveness data of the marketed edaravone injection, and by changing the route of administration, the edaravone injection is modified into an oral tablet, which improves the edaravone injection.
Bong oral bioavailability
.
The drug has completed a phase 1 clinical trial for acute ischemic stroke indications in Australia, and has been approved for a phase 1 bridging registration clinical application for acute ischemic stroke in China
This time in the United States, the orphan drug qualification for TTYP01 tablets is a new indication-amyotrophic lateral sclerosis
.
Amyotrophic lateral sclerosis, commonly known as "gradual freezing syndrome", is a fatal neurodegenerative disease characterized by the progressive degeneration of brain and spinal cord motor neurons
According to the press release of Aozong Bio, TTYP01 oral tablets have better safety than edaravone injection by intravenous drip, and patients can choose to increase the dose of the drug to achieve better clinical effects
.
Moreover, TTYP01 tablets have the potential to provide ALS patients with continuous treatment for more than one year
In addition to stroke and ALS, Aozong Bio is also simultaneously conducting research on the treatment of Alzheimer's disease (AD) and non-alcoholic steatohepatitis (NASH) with TTYP01 tablets, and plans to submit them in China and the United States in 2021.
