May witnessed the approval of Pfizer’s Talzenna, Nyprax’s Tukysa, Drug Houses’ Ajovy in Singapore
In Singapore, the Health Sciences Authority has approved three new products in May.
Ajovy approved for migraine in adults
Tuksya approved for breast cancer
Talzenna approved for breast cancer
Ajovy is used to prevent migraines in adults. The drug is proved to reduce migraine days by 50%. In patients with chronic migraine, the drug reduced the migraine days by five days compared to 3.2 days in the placebo arm. In patients with episodic migraine, the drug reduced migraine days by 3.5 days a month compared to 2.2 days in the placebo arm.
The drug is marketed by Teva in the United States and Europe.
Tuksya is indicated along with trastuzumab and capecitabine for patients suffering from unresectable or metastatic HER2-positive breast cancer. The drug is indicated in patients who were already treated with other therapeutic alternatives.
Median amount of time without progression is 7.8 months in patients administered with Tuksya compared to 5.6 months in patients administered with trastuzumab and capecitabine alone.
The product has been approved under Project Orbis in the USA. The US FDA has collaborated with the Australian Therapeutic Goods Administration (TGA), Health Canada, Health Sciences Authority (HSA, Singapore) and Swissmedic (SMC, Switzerland) for this review.
TALZENNA (Talazoparib )
Talzenna is indicated for BRCA mutated human epidermal growth factor receptor 2 (HER2) negative breast cancer.
During the clinical trials, median time for the disease progression was 8.6 months in patients administered with Talzenna compared to 5.6 months in patients administered with standard of care.
The drug is marketed by Pfizer in Singapore.