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Molnupiravir approval sought to target early stage COVID-19 cases: Natco vice chairman

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After an outcry for remdesivir, there is now yet another experimental anti-viral drug – Molnupiravir to deal with COVID patients. Hyderabad-headquartered Natco Pharma on Monday, April 26th, disclosed to the bourses that it has applied to the Central Drugs Standard Control Organization (CDSCO) in India for approval of Phase-III clinical trial of Molnupiravir Capsules for the treatment of COVID-19 positive patients and is also seeking an emergency approval of the drug based on “compassionate use” for patients.

Financial Express Online spoke to Natco Pharma vice chairman Rajiv Nannapaneni and began by asking how does Molnupiravir differ from remdesivir and how is it expected to help. He says: “remdesivir is given in a hospital setting and is administered as an injection when the oxygen levels drop. In the case of Molnupiravir, if a person is tested positive for COVID, then depending on the advice of the physician, a patient may be allowed by the doctor to immediately start taking this oral therapy for five days. It will therefore help ensure that the patient can get to avoid getting to the hospital and thereby reduce the load on the hospitals.”

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Natco Pharma’s involvement with Molnupiravir and its relation with the US pharma giant Merck (MSD), which is behind the development of this drug, is however not clear and also not spelt out in the note to the bourses.

Nannapaneni says the company has also applied to the DCGI for grant of an emergency approval of this drug based on “compassionate use” for patients faced with life-threatening condition.

Earlier, in the day, the company informed the bourses about the application to the DCGI and in a note to the stock exchanges says, “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.”

Financial Express Online asked India’s well known medical scientist and top vaccine expert Dr Gagandeep Kang on what she thought of Molnupiravir, which has been evaluated in phase 2 studies and she says: “It is looking pretty good and is a drug that was designed by Ridgeback Biotherapeutics and later bought by Merck. The data from phase 2 is looking good but it needs to be evaluated in proper phase 3 studies.”

Dr Kang, who is also the professor at the Christian Medical College, Vellore, however reminds that “no drug is going to be a perfect solution because COVID is not like an infection that has to be countered by an antibiotic that will go and kill the bug.” Please remember, she says, “severe disease in COVID is happening because of a body’s reaction to a viral infection and it is not just direct damage that needs to be checked like in most bacterial infections. So, we should not expect an anti-viral for a respiratory infection to be a magic solution to all our problems.”

In the context of an outcry for remdesivir, Dr Soumya Swaminathan, the chief scientist at the World Health Organisation (WHO) and one who has looked at public health in India earlier as the secretary general of the Indian Council of Medical Research (ICMR) has maintained and had told Financial Express Online earlier in the backdrop of rising demand for remdesivir: “unnecessary use of antivirals (including remdesivir) and also antibiotics is not warranted in all cases of COVID-19” and that it is important that physicians follow evidence-based clinical care guidelines and confine to the standard protocols.

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