Sanofi gets CDCSO panel okay to study Antiasthmatic drug Dupilumab

This approval is subjected to the condition that in India the study should be considered as Phase III and, accordingly, only the Phase III part of the proposed study is to be conducted in India.

Furthermore, the conditions also include that the firm should perform the QuantiFERON-TB Gold test during the screening visit to exclude latent- TB subjects from the study, and women of child bearing potential should be excluded from the study.

This came after drug maker Sanofi presented protocol no. LPS16676, Version: 5.0 dated 28 JAN 2021 before the committee at a recent SEC meeting for pulmonary.

Dupilumab belongs to a class of drugs called interleukin inhibitors. It is indicated for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Dupilumab is a fully human monoclonal antibody of the immunoglobulin G4 subclass that binds to the interleukin-4 (IL-4) receptor, inhibiting the receptor signaling pathways. As an interleukin-4 receptor alpha antagonist, dupilumab inhibits the signalling of pro-inflammatory cytokines, called interleukins (IL), that induce inflammatory and immunological reactions in several atopic or allergic conditions, such as eczema, allergic reactions, and rhinosinusitis. Dupilumab was generated by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture.

Dupilumab can be used with or without topical corticosteroids. It is also indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

At a recent SEC meeting for pulmonary, the committee examined the proposed study protocol no. LPS16676, Version: 5.0 dated 28 JAN 2021 presented by drug-maker Sanofi.

Analyzing the risk versus benefit to the patients, the committee observed that the safety profile of the investigational drug from various preclinical and clinical phase studies was presented to the committee.

In addition, in line with the innovation versus existing therapeutic option, the expert panel found that the study is to assess the effect of Dupilumab on preventing or slowing the rate of lung function decline by Week 52 (year 1) compared to placebo in a population with moderate to severe asthma.

Furthermore, the committee also observed that the test drug may potentially provide an alternative treatment option for patients with uncontrolled moderate to severe asthma.

The committee noted that the test drug is not approved in India and there is no available data on the test drug's use in pregnant women to inform any drug associated risk. Human IgG antibodies are known to cross the placental barrier; therefore, test drugs may be transmitted from the mother to the developing fetus.

After detailed deliberation, the committee recommended the grant of permission to conduct the study with the following conditions:

1. In India, the study should be considered as Phase III, and accordingly, only the Phase III part of the proposed study is to be conducted in India.

2. The firm should perform the QuantiFERON-TB Gold test during the screening visit to exclude latent- TB subjects from the study.

3. Women of childbearing potential should be excluded from the study. The firm should perform a serum pregnancy test during screening of women of child bearing potential in the trial.

In addition, the expert panel also directed the firm that it should submit an India specific protocol addendum to CDSCO.