FDA says sarcoma drug Ridaforolimus has reached the primary end point of the study

It is reported that the United States Health Regulatory Agency said on Friday that Merck Pharmaceuticals' ridaforolimus tablet has reached the main study end point - reducing the risk of progression or death of patients with metastatic soft tissue sarcoma or osteosarcoma by 25%.

A staff-examined document published by the Food and Drug Administration also stated that the clinical study did not show that the patented therapeutic drug named Taltorvic had new or unexpected signs of safety issues.

The external expert consultation team will vote on the drug on Tuesday. The team can recommend that the FDA approve the drug. The FDA will consider the findings of the panel of experts when making the final decision.

Sarcoma is a type of invasive tumor of the human connective tissue. The National Cancer Institute estimates that approximately 11,000 Americans were diagnosed with soft tissue sarcomas in 2011, of whom approximately 4,000 died of the disease.

Osteosarcoma is formed by bone cells. The Institute estimates that 2,890 people will suffer from the disease in the United States in 2012, including 1,400 deaths.

Merck is working with the small company Ariad Pharmaceuticals to develop the drug as a maintenance treatment for adults and as a maintenance treatment for children aged 13 to 17 years who have completed at least 4 cycles of chemotherapy and have no evidence of disease progression.

Federal officials granted the drug an orphan drug status, which means that the disease treated by the drug affects less than 200,000 people in the United States. If approved for sale, the drug will be granted exclusive sales rights for 7 years.

Ridaforolimus aims to block a protein called mTOR, which is a central regulator of cancer cell survival and growth.

According to Thomson Pharmaceuticals, Wall Street analysts in the past estimated that the drug's annual sales will reach an average of $28.3 billion by 2015.

The two companies submitted an application to the European Medicines Agency in August last year.

If the drug is approved, the two companies will jointly promote the drug in the United States.

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