New Delhi: Pharmaceutical major AstraZeneca has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to import and market Andexanet alfa powder for solution for infusion 200 mg indicated for patients treated with FXa inhibitors (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
However, this approval is subject to a condition that the firm should conduct the Phase IV clinical trial of Andexanet alfa for injection.
This came after the drug major AstraZeneca presented its proposal to import and market Andexanet alfa solution for injection indicated for patients treated with FXa inhibitors (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding with a waiver of local Phase III clinical trial.
Andexanet alfa is a recombinant Factor Xa used to reverse anticoagulation caused by rivaroxaban and apixaban.
Andexanet alfa works by binding to Factor Xa inhibitors and prevent them from interacting with endogenous Factor Xa. It displayed high affinity to apixaban, betrixaban, edoxaban and rivaroxaban. However, the effectiveness of andexanet alfa on treating bleeding related to any FXa inhibitors other than apixaban and rivaroxaban was not demonstrated, thus such use is limited.
At the recent SEC meeting for Cardiovascular and Renal held on 11th October 2023, the expert panel reviewed the proposal to import and market Andexanet alfa solution for injection indicated for patients treated with FXa inhibitors (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding with waiver of local Phase III clinical trial presented by the drug major AstraZeneca.
The committee noted that the drug is approved in the US, Japan, Australia, Switzerland, UK, Canada, EU. In addition, the expert panel found that there is an unmet medical need.
After detailed deliberation, the committee recommended a grant of permission to import and market the drug subject to the condition that the firm should conduct a Phase IV clinical trial in the country.
Accordingly, the expert panel suggested that the firm should submit the Phase IV protocol to CDSCO for evaluation within three months of the grant of marketing authorization.
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