India: CDSCO: Drug Approvals - November 2017

Last Updated: 5 February 2018
Article by Singh & Associates

Most Read Contributor in India, December 2018

The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.

Below is the list of drug approvals by the CDSCO in November 2017.

1. Midostaurin 25 mg Capsules: On November 09, 2017, CDSCO approved Midostaurin. Midostaurin Capsules are indicated for use:

  • In combination with standard induction and consolidation chemotherapy followed by single agent in maintenance of therapy for adult patients newly diagnosed with Acute Myeloid Leukemia (AML) who are FLT-3 Mutation positive.
  • For the treatment of adult patients with Advanced Systemic Mastocycosis (Advanced SM)1.

The approval for Midostaurin Capsules was given to Sandoz Private Limited.

At the technical advisory meeting of the Oncology & Haematology committee, at CDSCO headquarters on 18.07.2017, the committee opined that Midostaurin application of Sandoz falls under the criteria of clinical trial waiver as the said indications are conditions for which there is no therapy.

The committee also observed that the drug was granted breakthrough therapy orphan drug designation by US & EU both. Hence, the committee recommended for grant of permission to import & market the drug for the said indications with waiver of local clinical trial2.

About Midostaurin

Midostaurin is an oral, targeted therapy, a type of treatment that interferes with certain pathways that are involved in the growth, progression and spread of cancer. Midostaurin inhibits multiple kinases, including FLT3, which help regulate many essential cell processes, interrupting cancer cells' ability to grow and multiply. Midostaurin induces cell death in leukemic cells expressing FLT3 ITD or TKD mutant receptors, or in cells overexpressing FLT3 wildtype receptors. Midostaurin also inhibits the activity of the kinase KIT (wild type and D816V mutant), inhibiting mast cell proliferation, survival and histamine release. In addition, Midostaurin inhibits several other receptor tyrosine kinases such as PDGFR alpha/s, VEGFR2, and members of the serine/threonine kinase PKC family, inhibiting signaling of the respective growth factors in cells, resulting in growth arrest.

About Acute Myeloid Leukemia (AML)

AML is the most common acute leukemia, or blood cancer in adults; it accounts for approximately 25% of all adult leukemias worldwide, with the highest incidence rates occurring in the US, Europe and Australia. It also has the lowest survival rate amongst all adult leukemias. In AML, white blood cells are not able to mature and instead build up an accumulation of "blasts," blocking room for normal blood cells. Mutations in specific genes, such as FLT3, are found in many cases of the disease.

About Advanced Systemic Mastocycosis (ASM)

In advanced SM, the uncontrolled growth of neoplastic mast cells causes organ damage (e.g., liver dysfunction), low blood count and weight loss. People with the disease also suffer from debilitating systemic symptoms such as pruritus (severe itching of the skin) caused by mast cells releasing inflammatory mediators, such as histamine into the blood.

2. Tenofovir Alafenamide Fumarate bulk & 25 mg capsules: On November 10, 2017, CDSCO approved Tenofovir Alafenamide Fumarate bulk & 25 mg capsules3.

Tenofovir Alafenamide Fumarate bulk & 25 mg capsules are indicated:

  • For the treatment of chronic Hepatitis B virus infection in adults with compensated liver disease.

The approval for Tenofovir Alafenamide Fumarate bulk & 25 mg capsules was given to Mylan Labs.

Mylan Labs presented the data on the drug including data from global clinical trials conducted, in which India was a participating country. The data presented shows that Tenofovir Alafenamide and TDF are equivalent in terms of efficacy but Tenofovir Alafenamide has reduced toxicity. The data was presented on 14.06.2017 before the CDSCO's advisory committee for Antimicrobial & Antiviral drugs.

After review of the data, the committee considered the request for waiver of local clinical trial and recommended for conduct of the BE study as per the protocol submitted4.

Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor and a prodrug of tenofovir. It was developed by Gilead Sciences for use in the treatment of HIV infection and chronic hepatitis B, and is applied in the form of tenofovir alafenamide fumarate (TAF).

3. Ceritinib150mg hard gelatin capsule: Additional indication approved

In the Subject Expert Committee (SEC) meeting of Oncology & Haematology held on 14.11.2017 – Novartis presented their proposal along with the clinical data for the proposed indication. The Committee noted that anaplastic lymphoma kinase (ALK) - positive advanced non- small cell lung cancer (NSCLC) is a serious/life threatening rare disease.

After detailed deliberation the committee recommended for approval of the proposed additional indication for Certinib:

  • As a monotherapy for first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non- small cell lung cancer (NSCLC)5.

4. Filgrastim/ Filgrastim Solution for Injection: Additional indications approved

In the Subject Expert Committee (SEC) meeting of Oncology & Haematology held on 14.11.2017, Intas presented their proposal for additional indications. The indications are already approved in many countries including USA & Europe. After detailed deliberation, committee recommended for approval of the following three additional indications6 for Filgrastim.

  1. For chronic use to reduce the incidence and duration of sequeale of severe neutropenia (e.g. fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia or idiopathic neutropenia.
  2. To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome).
  3. For the treatment of persistent neutropenia (ANC≤1.0 x 109 /L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

5. Liraglutide Injection: Additional indications approved

In the Subject Expert Committee (SEC) meeting of Endocrinology & Metabolism held on 09.11.2017, Novo Nordisk presented supportive data including clinical data for the proposed expansion of the indication of Liraglutide Injection.

The committee after detailed deliberation recommended that the indication may be expanded as follows:

  • To reduce the risk of major adverse cardiovascular events in adults with Type 2 diabetes mellitus and established cardiovascular disease.








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