FDA approved breakthrough therapy for autism treatment
The US Food and Drug Administration (FDA) recently recognized Roche Pharmaceutical's Balovaptan as a breakthrough treatment.
The Swiss pharmaceutical company on January 29 announced that Balovaptan, although still in development stage and expected to be completed by 2020, has shown the ability to improve communication and social interaction of people with ASD.
The results of the Balovaptan study presented at the international conference on autism research in May 2017 also showed that the drug is safe and well tolerated.
A lab of Roche in Switzerland - (Photo: Reuters).
The next stage of research on children and adolescents is underway.
If the results continue to be positive, Balovaptan can become the first pharmacological therapy to help improve the main symptoms of ASD, such as difficulties in communication, interaction and repetition, so far no drugs are available. Whichever is FDA-compliant.
"We are looking forward to working closely with the FDA in hopes of bringing this drug to people with ASD as soon as possible" - Reuters quoted Sandra Horning, a leader of Roche's global product development department. , said.
Balovaptan is one of the potential drugs being studied by Roche. Certification of FDA breakthrough treatment is often aimed at promoting potential drugs.
ASD is a lifelong syndrome with major symptoms that are difficult to treat and affect the behavior, communication and interaction of people with ASD. The incidence of ASD in boys is usually four times higher than for girls.
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