India Pharma Outlook Team | Wednesday, 08 November 2023
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) have approved this new indication for anastrozole, a hormone therapy used to treat breast cancer in postmenopausal women. Anastrozole is already approved for the treatment of breast cancer in postmenopausal women and has been used as an alternative to prevention. This new indication of anastrozole was licensed to Accord Healthcare Ltd on November 6, 2023. This notification confirms the authorization for prophylaxis in postmenopausal women at moderate or high risk of developing the disease. The evidence was based on the IBIS-II study, an international randomized, double-blind, placebo-controlled trial, which showed that the anastrozole group developed fewer breast cancers than the placebo group. Breast cancer is the most common type of cancer in the UK.
Most women diagnosed with breast cancer are over the age of 50, but younger women can also develop breast cancer. About 1/7 of women will be diagnosed with breast cancer in their lifetime. Treatment is taken as a 1 mg tablet once a day for 5 years, as per pharmabiz. Anastrozole is an aromatase inhibitor . It reduces the amount of estrogen hormone that the patient's body produces by inhibiting the activity of an enzyme called "aromatase". The most common side effects of the drug are fever, weakness, joint pain/stiffness, arthritis, rash, nausea, headache, osteoporosis and depression. As with any medication, the MHRA will keep the security and viability of anastrozole beneath near audit. Anybody who suspects they are having a side impact from this medication are energized to conversation to their specialist, drug specialist or nurture and report it specifically to the Yellow Card plot, either through the site or by looking the Google Play or Apple App stores for MHRA Yellow Card.