pharmaceutical

FDA Approved Drugs: August, 2023

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Izervay (avacincaptad pegol sodium)

FDA approved Izervay, a complement C5 inhibitor, for the treatment of geographic atrophy secondary to age-related macular degeneration, according to a press release from Astellas Pharma.

The approval was based on the data from the GATHER1 and GATHER2 phase 3 clinical trials in which monthly 2 mg injections of Izervay (avacincaptad pegol intravitreal solution) showed a statistically significant reduction (P < .01) in the rate of geographic atrophy growth at 12 months. The slowing in disease progression was seen as early as 6 months, while up to a 35% reduction in progression occurred in the first year of treatment.

Talvey (talquetamab-tgvs)

FDA granted accelerated approval of Talvey (talquetamab-tgvs), a first-in-class bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

Talvey is a bispecific T-cell engaging antibody that binds to the CD3 receptor on the surface of T cells and G protein-coupled receptor class C group 5 member D (GPRC5D) expressed on the surface of multiple myeloma cells, non-malignant plasma cells and healthy tissue such as epithelial cells in keratinized tissues of the skin and tongue.

Elrexfio (elranatamab-bcmm)

FDA granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Sohonos (palovarotene)

FDA approved Sohonos (palovarotene) capsules as a retinoid indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).

The FDA approval was based on the pivotal efficacy and safety data from the Phase 3 MOVE trial, the first and largest multicenter, open-label trial in adult and pediatric patients.

Veopoz (pozelimab-bbfg)

FDA approved Veopoz (pozelimab-bbfg) for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy. Veopoz is the first and only treatment indicated specifically for CHAPLE. Veopoz, a fully human monoclonal antibody, is designed to target complement factor C5, a protein involved in complement system activation.

The FDA approval was based on results from a Phase 2/3 open-label trial that investigated the efficacy and safety of pozelimab in 10 patients aged 3 to 19 (median of 8.5 years).

Eylea HD (aflibercept)

FDA approved EYLEA HD (aflibercept) Injection 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). This is the first and only treatment approved in wAMD and DME for immediate dosing at 8-week and up to 16-week intervals following three initial monthly doses

Approval was based on the pivotal PULSAR and PHOTON trials in which EYLEA HD demonstrated clinically equivalent vision gains to EYLEA (aflibercept) Injection 2 mg that were maintained with fewer injections.

Tyruko (natalizumab-sztn)

FDA approved biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics. Tyruko is approved to treat all indications covered by the reference medicine and is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS).

Sandoz entered into a global commercialization agreement for Tyruko with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibility for development, manufacturing and supply of the active substance in Tyruko. Through an exclusive global license, Sandoz has the rights to commercialize and distribute it in all markets.

FDA Approved Drugs: October, 2022

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Imjudo (tremelimumab)

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer. HCC is the most common type of liver cancer.

Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death.

The approval was based on positive results from a Phase III trial (HIMALAYA), which demonstrated that patients treated with the combination of Imjudo and Imfinzi experienced a 22% reduction in the risk of death compared to sorafenib, an oral kinase inhibitor used to treat late-stage liver cancer. The results of the Phase III trial also showed evidence that the combination therapy allowed an estimated 31% of patients to live three years after administration, compared to 20% of sorafenib-treated patients, who showed the same longevity.

Beyond HIMALAYA, Imjudo is being tested in combination with Imfinzi across multiple tumour types including locoregional HCC (EMERALD-3), SCLC (ADRIATIC) and bladder cancer (VOLGA and NILE).

Imjudo is also under review by global regulatory authorities in combination with Imfinzi and chemotherapy in 1st-line metastatic NSCLC based on the results of the POSEIDON Phase III trial, which showed the addition of a short course of Imjudo to Imfinzi plus chemotherapy improved both overall and progression-free survival compared to chemotherapy alone.

Tecvayli (teclistamab-cqyv)

Janssen’s Tecvayli (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

  • Multiple myeloma is a cancer of the plasma cells in the bone marrow. Plasma cells normally make antibodies which fight infection, but when the plasma cells become malignant and develop into multiple myeloma, the myeloma cells proliferate and replace normal cells in the bone marrow.
  • Tecvayli targets both BCMA (B-cell maturation antigen) and CD3, the T-cell receptor. BCMA is expressed at high levels on multiple myeloma cells. Tecvayli works by redirecting CD3-positive T-cells to BCMA-expressing myeloma cells to induce the killing of the cancer cells.
  • Warnings and precautions associated with Tecvayli include hepatotoxicity, infections, neutropenia, hypersensitivity and other administration reactions, and embryo-fetal toxicity.
  • Common adverse reactions observed in clinical trials include cytokine release syndrome, neutropenia, and anemia. Infections were frequent with the most common being upper respiratory tract infections and pneumonia. Hypogammaglobinemia and neurotoxic events were also observed in some patients.

Impact of Coronavirus (COVID19) on India Pharmaceuticals

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Impact of Coronavirus (COVID19) on India Pharmaceuticals

India is one of the largest providers of generic drugs worldwide. India pharmaceutical industry supplies approximately 50% of vaccines worldwide, 40% of generics in the United States and 25% of all medicines in the United Kingdom. India exports bulk drugs, intermediates, drug formulations, biologicals, Ayush & herbal products, and surgicals to various countries.

According to the India Brand Equity Foundation (IBEF), the Indian pharmaceutical sector had a market size of USD 33 Billion in 2017. India’s pharmaceutical exports had witnessed an increase from USD 19.14 Billion in 2019 to USD 17.27 billion in 2018.

The novel coronavirus (COVID-19) outbreak had a negative impact on the India pharmaceutical industry in the following ways:

  • India has restricted the export of several drugs such as paracetamol, antibiotics such as tinidazole and erythromycin, hormone progesterone, which is used in the contraceptive pill, and vitamins B12, B1 and B6. These drugs account for approximately 10% of all India’s pharmaceutical exports.
  • The Indian government have imposed limits on the export of 26 pharmaceutical ingredients
  • Indian pharmaceutical companies are now close to exhausting their supply of raw materials such as active pharmaceutical ingredients (APIs). Moreover, the inventories related to the pharmaceutical ingredients are running low.
  • Several pharmaceutical companies who have contracts with domestic clients and various state governments to supply medicines have been crippled, as manufacturing has come to a halt due to a shortage of raw materials from China
  • Pharmaceutical companies are not able to procure pharmaceutical ingredients for Mintelukast, used for asthma, pain medication Nimesulide, and Amoxicillin, Ofloxaicin, and Chloramphenicol, which are used to treat bacterial infections, and antibiotic Metronidazole
  • Small and medium companies have been most  affected as they depend on traders and keep lower inventory
  • There is a drastic increase of 20-30% in the prices of raw materials used in medicines like Amoxicillin and Paracetamol.
  • The pharmaceutical logistics is facing the difficulties in receiving the raw material from other parts of the country