Natco Pharma seeks approval for Molnupiravir capsules for use in COVID-19 treatment
Hyderabad,
Apr
26:
Natco
Pharma
Limited
on
Monday
said
it
applied
to
the
Central
Drugs
Standard
Control
Organisation
(CDSCO)
for
approval
of
Phase-III
clinical
trial
of
Molnupiravir
Capsules
for
the
treatment
of
COVID-19
positive
patients.
American
pharma
major
Merck
along
withRidgeback
Biotherapeuticshasdeveloped
Molnupiravir(MK-4482).
According to a press release from the city-based drug maker, pre-clinical data have shown that Molnupiravir has broad anti-influenza activity, including highly potent inhibition of SARS-CoV-2 replication.
"Patients treated with Molnupiravir achieved response within 5 days of therapy indicating that the duration of treatment with Molnupiravir is short, with the additional advantage of being an oral therapy," it said.
NATCO is hoping that CDSCO would give emergency approval of this drug based on "compassionate use" for patients.
"Compassionate use" approval is given for investigational drugs so that a patient with an immediately life-threatening condition can gain access to the drug.
The company is ready to launch the product this month if approval is given.
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