Cipla Pharmaceutical launches generic remdesivir under brand name Cipremi

Cipla Pharmaceutical launches generic
remdesivir under brand name Cipremi

Indian drug-maker Cipla has launched remdesivir under the brand name Cipremi (remdesivir lyophilised powder for injection 100 mg) and will be marketing and supplying the drug through both government and open market channels.

The Mumbai-headquartered company said it will be commercialising remdesivir through its own facilities and partnered sites.

The drug has been approved for adult and paediatric patients hospitalised with suspected or laboratory confirmed COVID-19 infection, particularly those on oxygen support.

Cipla, along with Hetero Pharma, has received approval from the drug regulator to manufacture and market the COVID-19 medicine in India.

Hetero Pharma has launched its generic version of remdesivir under the brand name Covifor and will be selling 100 mg injectable vials for estimated Rs 5000 to Rs 6000 per vial. As per the ministry's dosing recommendation, patients are to be given 200 mg injection of remdesiver on day 1 followed by 100 mg IV daily for 5 days.

Cipla has yet not disclosed it’s pricing for the generic remdesivir.

ICMR has approved remdesivir under Emergency Use Authorisation (EUA) treatment for patients with severe COVID-19 infection. The drug has been included in the Ministry of Health's revised 'Clinical Management Protocols for COVID-19' as an "investigational therapy".

Remdesivir is the only US FDA approved EUA treatment for adult and paediatric patients hospitalised with suspected or laboratory confirmed COVID-19 infection.

Drug Controller General of India (DCGI) has granted approval for Cipla's drug for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need.

Cipla in a statement said, “As part of a risk management plan, Cipla will provide training on use of the drug, informed patient consent documents, conduct post marketing surveillance as well as conduct a Phase IV clinical trial on Indian patients.”

Cipla has cited preliminary results from the ACTT-1 (Adaptive COVID-19 Treatment Trial 1) study1, which is a randomised clinical trial conducted with remdesivir in 1063 patients -- most on oxygen support -- over 60 centres across the US, Europe and Asia.

The study demonstrated faster time for clinical recovery in hospitalised patients as compared to placebo.

Patients were either receiving high flow oxygen or non-invasive ventilation, some were on mechanical ventilator. The mortality rate in the study was 7.1 percent among given remdesivir and 11.9 percent in those given placebo.

In May, Gilead Sciences had extended voluntary non-exclusive licence to Cipla, Hetero to manufacture and market generic versions of remedisvir. Zydus Cadila, Mylan and DRL are other firms with licences from Gilead and are awaiting DCGI nod to start supplies in India. BDR Pharma has also submitted application to DCGI to make and sell Remdesivir in India.