Shares of Natco Pharma, on Monday, rose 4 per cent to Rs 935 on the BSE in intra-day trade after the company received emergency use approval for Baricitinib tablets for Covid-19 treatment.
“The company has received Emergency Use approval for Baricitinib tablets, 1mg, 2mg and 4mg strengths from Central Drugs Standard Control Organization (CDSCO) in India. Baricitinib in combination with Remdesivir is used for treatment of COVID-19 positive patients,” Natco Phamra said in exchange filing.
Natco will be requesting a Compulsory License based on emergency use and in light of the grave and serious public health emergency across India due to the Pandemic. The company is ready to launch the product this week, so as to make the product available to suffering patients across India, it said.
Last week, Natco Pharma announced that it had applied to the CDSCO in India for approval of Phase-III clinical trial of Molnupiravir Capsules for the treatment of COVID-19 positive patients.
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.
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 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, the company said.