CDSCO expert panel rejects Glenmark Favipiravir-Dexamethasone combination for COVID treatment
New Delhi: In a major setback to Glenmark, the Subject Expert Committee of the apex the drug regulator, Central Drugs Standard Control Organisation (CDSCO) has declined to clear the drugmaker's proposal to conduct of phase III Clinical Trial of Favipiravir along with Dexamethasone for Covid-19 treatment.
The Mumbai-based drugmaker had earlier introduced a stronger version of Favipiravir in the strength of 400 mg under the brand name FabiFlu for the treatment of mild and moderate COVID-19 in India.
However, the firm has lately submitted to combine the antiviral drug, Favipiravir along with steroid Dexamethasone. Favipiravir is presently the subject of several trials around the world as a potential treatment for Covid-19, while Dexamethasone is a steroid used to suppress skin allergies and treat rheumatic disorders and is part of India's approved clinical management protocol for Covid-19.
The firm presented its proposal for conducting a phase III Clinical Trial of Favipiravir along with Dexamethasone before the CDSCO expert panel. In phase 3 clinical trials, a drug is tested on thousands to establish safety and efficacy.
However, the panel did not recommend the conduct of the clinical trials in its present form in light of the fact that "the justification presented for use of favipiravir and dexamethasone in all patients of moderate COVID in the test arm is not adequate".
After detailed deliberation, the committee further observed that other steroids such as methylprednisolone is also recommended for COVID-19 treatment. Hence, the use of Favipiravir with Dexamethasone in the proposed study is not convincing.
The panel highlighted various concerns that prompted it to reject the proposal that read;
- Dose and duration of Dexamethasone in COVID patients vary with the severity of the disease and other conditions. However, in the protocol, fixed-dose and duration have been proposed for dexamethasone administration.
- The standard arm will not be given steroid which is not as per the National guidelines for clinical management of COVID patients.
- As per the protocol, all moderate patients may not require oxygen which is not justified.
- Other steroids such as methylprednisolone are also recommended for COVID-19 treatment. Hence, the use of Favipiravir with Dexamethasone in the proposed study is not convincing.
- The firm has already been granted permission to conduct an active PMS study with Favipiravir. Report of the same is awaited.
To elaborate, PMS is also known as Phase IV clinical trials that are done to determine the efficacy of the drug once it is launched in the market for use.