Drug manufacturer Roche has been granted breakthrough status by the FDA
for its latest drug Balovaptan!
The FDA has granted breakthrough status to Roche’s new autism drug,
Balovaptan
.
Balovaptan
aims to treat autism by modulating the activity of vasopressin, which is a hormone that researchers have been trying to target for several years.
Balovaptan
works by targeting and blocking the activity of the V1a vasopressin receptor subtype.
Balovaptan
is currently in its second stage of testing
,
and
the results are looking good.
Reuters
announced earlier that the FDA had granted breakthrough status to
Balovaptan
in the hopes that the program would be able to speed through the development stage and be made available on the market.
Vasopressin is a neuropeptide that helps neurons in the brain communicate with each other and researchers believe could play a pivotal role in social bonding.
In regard to
autism, higher levels of vasopressin in the blood correspond with better social functioning in individuals.
The pharmaceutical industry has had a rough time over recent years trying to develop an effective treatment for autism, with a string of product failures in products such as
Novartis
,
Roche
and
Seaside Therapeutics.
While there have been several setbacks recently, researchers are hopeful that there are breakthroughs on the way with medical research into autism
being conducted
around the world at an increasing pace.
Roche has approached the challenging problem from a different direction with its latest drug. They believe that by blocking the activity of one hormone at the receptor, they will be able to help boost social functioning and avoid any negative side-effects. One of the biggest side-effects that have
been discovered
is a
risk
of increased aggression. Trials are still ongoing, but early testing and the recent FDA breakthrough status which
was awarded
to
Balovaptan
are promising.