The first generic version of Apalutamide, a drug used in the treatment of prostate cancer, has been introduced in India at one-third the original cost.
The drug, used to treat metastatic castration-sensitive prostate cancer as well as non-metastatic castration-resistant prostate cancer, is set to be available across the country.
The generic drug branded Apatide will cost Rs 22,500 for a bottle of 60 tablets and Rs 45,000 for 120 tablets, said Mumbai-based BDR Pharmaceuticals, the manufacturer of the generic version.
Patients generally need this drug for two months, with a gap of one week in between.
The drug originally developed by the Janssen Pharmaceutical Companies of Johnson & Johnson works by blocking the effect of androgens, a type of hormone, on the tumour. The US Food and Drug Administration approved the drug in February 2018.
According to BDR Pharmaceuticals, Apalutamide, in combination with anti-androgen therapy, has proven to significantly improve chances for survival within metastatic castration-sensitive prostate cancer patients.
“Apalutamide plus ADT (androgen-deprivation therapy) arm shows a significant decrease in the risk of disease progression and reduces risk of mortality by 35 percent,” the drugmaker said.
Raheel Shah, director of business development at BDR Group, said early identification of new molecules for life-threatening diseases encourages the company to advance the development and introduction of products through the strength of backward integration of developing and manufacturing active pharmaceutical ingredients to aid patients.
According to the company, Apalutamide is likely to significantly improve overall survival and radiographic progression-free survival in patients.
Prostate cancer cases
As per clinical data during the phase 3 clinical trials, Apalutamide, in combination with anti-androgen therapy, significantly improved median metastasis-free survival by two years.
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The median progression-free survival for Apalutamide plus ADT arm was 40.5 months compared with 14.7 months for the placebo arm plus ADT, representing a 71 percent decrease in the risk of disease progression or death.
Also, patients maintained overall health-related quality of life with the addition of Apalutamide to androgen-deprivation therapy, the company said.
Worldwide, prostate cancer cases are expected to grow to 1.7 million and result in 499,000 deaths by 2030. In India, prostate cancer is the No. 2 cause of cancer and usually affects men above 65 years of age. However, there has been an increase in reports of cancer in men in the age group of 35-44 and 55-64, mainly in urban areas.
Old age, obesity, improper diet, and genetic alterations have been identified as some of the main factors towards the increased incidence of prostate cancer.
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