Cipla gets CDSCO panel nod to market antineoplastic drug Hydroxyurea

New Delhi: In a significant development, drug-major Cipla has got a go ahead from from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) for marketing antineoplastic agent Hydroxyurea capsules 500mg.

However, the approval is subjected to condition that firm should conduct Post Marketing Survey Study. Accordingly, the firm is told to submit PMS study protocol within 03 months of approval of the product.

This came in line with the proposal presented by the pharma major Cipla for manufacturing & marketing of Hydroxyurea capsules 500mg along with published data for the indication, prevention of recurrent painful vasoocclusive crises including acute chest syndrome in adults, adolescents and children older than 2 years suffering from symptomatic sickle cell syndrome.

Hydroxyurea is an antimetabolite used to treat sickle cell anemia crisis. It is an antineoplastic agent that inhibits DNA synthesis through the inhibition of ribonucleoside diphosphate reductase.

Hydroxyurea is converted to a free radical nitroxide (NO) in vivo, and transported by diffusion into cells where it quenches the tyrosyl free radical at the active site of the M2 protein subunit of ribonucleotide reductase, inactivating the enzyme. The entire replicase complex, including ribonucleotide reductase, is inactivated and DNA synthesis is selectively inhibited, producing cell death in S phase and synchronization of the fraction of cells that survive.

Repair of DNA damaged by chemicals or irradiation is also inhibited by hydroxyurea, offering potential synergy between hydroxyurea and radiation or alkylating agents.

Hydroxyurea also increases the level of fetal hemoglobin, leading to a reduction in the incidence of vasoocclusive crises in sickle cell anemia. Levels of fetal hemoglobin increase in response to activation of soluble guanylyl cyclase (sGC) by hydroxyurea-derived NO.

At recent SEC meeting for Oncology& Haematology dated 09.12.2021& 10.12.2021, in response to the drug major Cipla's proposal, the committee noted that Hydroxyurea capsules 500mg is already approved for the said indication in US, UK & included in National guideline.

After detailed deliberation, the committee recommended the grant of permission for marketing Hydroxyurea capsules 500mg for the applied indication subject to condition that firm should conduct PMS Study.

Accordingly, the firm should submit Post Marketing Survey (PMS) study protocol within 03 months of approval of the product.