However, this approval is subjected to the condition that the firm should conduct Phase IV clinical trial for which protocol should be submitted within 3 months of approval of the drug for review by the committee.
In addition, it is also directed that the drug be sold at retail under the prescription of the designated medical specialist only.
This came after the firm presented the raw data of the in-vitro comparative evaluation report of test drug vs innovator drug products before the committee.
Icatibant is a bradykinin B2 receptor antagonist used to treat acute episodes of swelling and inflammation associated with hereditary angioedema (HAE).
HAE is a rare disease characterized by an absent or dysfunctional C1 esterase inhibitor molecule (C1INH). C1INH is an important regulator in the metabolic pathways of complement, kinin-kallikrein and coagulation factors. The symptoms of the disease are due to local accumulations of bradykinin caused by excessive activation of the complement and kinin pathways as a result of the C1INH deficiency.
Icatibant inhibits bradykinin from binding to the B2 receptor, thus treating the symptoms of an acute HAE attack. Icatibant injection is used to treat sudden attacks of hereditary angioedema (HAE). Icatibant works by blocking a chemical in the body that causes swelling, inflammation, and pain for patients with HAE.
At the recent SEC meeting for Pulmonary held on 4th November 2022, the expert panel reviewed the raw data of the in-vitro comparative evaluation report of test drug vs innovator drug products presented by drug maker MSN Laboratories.
The committee noted that the drug is already approved in countries like the USA, Europe, Canada and Australia.
In addition, observing that there is an unmet medical need in the country, the expert panel cited that the drug is designated as an orphan drug and indicated for rare and life-threatening conditions.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the drug for the proposed indication, subject to the condition that the firm should conduct a Phase IV clinical trial for which protocol should be submitted within 3 months of approval of the drug for review by the committee.
Furthermore, the expert panel directed that the drug should be sold by retail under the prescription of the designated medical specialist only.
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