FGK Representative`s Pretomanid FGK (pretomanid)Receives Approval in Europe
We have one more startup to add to the list before we call it a day. ATAI Life Sciences, which likes to dabble with psychedelics in developing new therapies, has another mind bender in the works. They’ve kickstarted a new company to delve into formulations of N,N-dimethyltryptamine (DMT) —the active ingredient in ayahuasca — for new drugs to use in the mental health field. DMT acts as a partial agonist on a variety of 5-HT receptors, they say, which makes it a good candidate for patients not attracted to the potent brew featured on certain South American journeys. “These novel products are expected to simplify in-clinic administration and allow greater pharmacokinetic control of the psychedelic experience and its overall duration,” said Srinivas Rao, chief scientific officer of ATAI. “Patients may even be able to attend psychotherapy sessions later the same day.”
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its March 2020 meeting. In line with EMA’s measures to limit the spread of COVID-19, the meeting was held virtually.
TB Alliance, a non profit drug development organisation-is in advanced discussions with India’s drug regulator and has sought clinical trial waiver to launch its newly approved drug-Pretomanid in India, its officials present at the 50th Union World Conference on Lung health at Hyderabad told ET. Pretomanid, a new oral treatment is a shorter more convenient option for people with extensively drug resistant (XDR) TB.
Multinational pharmaceutical company Mylan is working with Drug Controller General of India (DCGI) to launch pretomanid, a medicine used to treat drug- resistant tuberculosis (TB), a top official of the US drug major has said.
MUMBAI: TB Alliance, the nonprofit group which has developed a treatment for extreme drug-resistant tuberculosis (XDRTB), said the drug will be priced such that it is affordable for patients and sustainable for the pharma companies manufacturing it. The treatment was approved by the US Food and Drug Administration earlier this month.
The LPAD pathway was established by FDA as a tool to encourage further development of antibacterial and antifungal drugs to treat serious, life-threatening infections that affect a limited population of patients with unmet needs.
Independent experts of an FDA advisory panel voted in favor of the not-for-profit TB Alliance’s treatment for drug resistant tuberculosis, as a part of a three-drug combination regimen.