Policy & Regulation
Gilead Submits New Drug Application to US Food and Drug Administration for Veklury for the Treatment of COVID-19
11 August 2020 - - US-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) has submitted a New Drug Application to the US Food and Drug Administration for Veklury (remdesivir), an investigational antiviral for the treatment of patients with COVID-19, the company said.

Veklury is currently available in the US under an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19.

The filing is the final tier of the rolling NDA submission that was initiated on April 8, 2020.

The filing is supported by data from two randomized, open-label, multi-center Phase 3 clinical studies of Veklury conducted by Gilead and the Phase 3 randomised, placebo-controlled study of Veklury conducted by the National Institute of Allergy and Infectious Diseases (NIAID).

These studies demonstrated that treatment with Veklury led to faster time to recovery compared with placebo and that a 5-day or 10-day treatment duration led to similar clinical improvement.

Across studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, with no new safety signals identified.

Veklury has been approved by multiple regulatory authorities around the world, including in the European Union and Japan.

In countries where Veklury has not been approved, including the United States, Veklury is an investigational drug and the safety and efficacy of remdesivir have not been established.

Veklury (remdesivir) is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens.

Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of Veklury for the treatment of SARS-CoV-2 infection, the virus that causes COVID-19, in different patient populations, formulations, and in combination with other therapies.

In the United States, Veklury (remdesivir) is authorised for use under an Emergency Use Authorization only for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19.

Severe disease is defined as patients with an oxygen saturation ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation.

Veklury must be administered via intravenous infusion and is supplied two ways: Veklury (remdesivir) for injection, 100 mg, lyophilized powder, or Veklury (remdesivir) injection, 100 mg/20 mL (5 mg/mL), concentrated solution.

Veklury is an investigational drug that has not been approved by the FDA for any use, and the safety and efficacy of Veklury for the treatment of COVID-19 have not been established.

This authorisation is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process.

There are limited clinical data available for Veklury. Serious and unexpected adverse events may occur that have not been previously reported with Veklury use. Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of Veklury.

The use of Veklury is contraindicated in patients with known hypersensitivity to remdesivir.

Transaminase elevations have been observed in healthy volunteers and patients with COVID-19 in clinical trials who received Veklury.

Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events.

Monitor renal and hepatic function prior to initiating and daily during therapy with Veklury; additionally monitor serum chemistries and hematology daily during therapy. Do not initiate Veklury in patients with ALT ≥5x ULN or with an eGFR
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