CDSCO Panel Tells MSN Lab to Produce Raw Data on Icatibant Injection
New Delhi: In response to drug maker MSN Laboratories' justification for bioavailability (BE) study waiver for Icatibant Injection 30mg/3ml (10mg/ml) vial, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has directed the firm to produce the raw data of the invitro comparative evaluation report of the test drug vs. innovator drug product to CDSCO for further review by the committee.
This came after the firm presented its justification for the BE study waiver for Icatibant Injection 30mg/3ml (10mg/ml) vial before the committee.
Icatibant is a bradykinin B2 receptor antagonist used to treat acute episodes of swelling and inflammation associated with hereditary angioedema (HAE).
Icatibant is a synthetic peptidomimetic drug consisting of ten amino acids and acts as an effective and specific antagonist of bradykinin B2 receptors. It has been approved in the EU for use in hereditary angioedema and is under investigation for a number of other conditions in which bradykinin is thought to play a significant role.
Bradykinin is a peptide-based hormone that is formed locally in tissues in response to trauma and acts to increase vessel permeability, dilate blood vessels and cause smooth muscle cells to contract. Bradykinin plays an important role in the mediation of pain as surplus bradykinin is partly responsible for producing signs of inflammation by activating bradykinin B2 receptors. In patients with HAE, they have an absent or dysfunctional C1-esterase inhibitor. This inhibitor is responsible for the production of bradykinin in which displacement of bradykinin from B2 receptors by icatibant has an inhibitory effect on the receptor for a relatively long time.
Previously, at the Pulmonary SEC meeting on March 29, 2022, the committee noted that Icatibant Injection 30mg/3ml (10mg/ml) is already approved in countries such as the United States, Europe, Canada, and Australia, and that the drug is also designated as an orphan drug and indicated for rare and life-threatening conditions, with an unmet medical need in the country.
Considering the above, the committee recommended the grant of permission to manufacture and market the drug subject to the condition that the firm conduct a Phase IV clinical trial for which protocol should be submitted to CDSCO within 3 months of the approval of the drug.
Furthermore, at a similar meeting, the committee opined that an opinion from an expert in internal medicine may be considered.
In continuation, at the SEC (Pulmonary) meeting dated July 6,2022, after considering the opinion of an expert in internal medicine, the committee recommended that the firm conduct a bioavailability (BE) study in a suitable number of healthy subjects after getting the protocol approved and submit the results prior to the manufacturing and marketing approval.
In view of the above, at the recent SEC meeting for pulmonary, the expert panel extensively reviewed MSN Laboratory's justification for the BE study waiver for Icatibant Injection 30mg/3ml (10mg/ml) vial before the committee.
After detailed deliberation, the committee opined to produce the raw data of the in vitro comparative evaluation report of test drug vs. innovator drug product to CDSCO for further review by the committee.
