Overview of European and American Drug Approval

  • Author:yaozh
  • Release on :2017-03-03
On February 27, following a few days ago, the European Commission approved the same new indications for lenalidomide, which allowed lenalidomide as a single drug, Autologous stem cell transplantation for newly diagnosed multiple myeloma adult patients with maintenance therapy.

February 28, the US FDA approved AstraZeneca compound drug Qtern for type 2 diabetes treatment. Qtern is a fixed dose of compound drugs, which consists of AstraZeneca active ingredient DPP-4 inhibitor sagreline and SGLT2 inhibitor daglitaxel composition. The drug was previously rejected by the FDA in 2015.

February 28, the US FDA approved Xermelo (telotristat ethyl) tablets and somatostatin similar drugs for the treatment of adult patients with cancer-like syndrome, only for the use of somatostatin analogue treatment of patients with uncontrolled disease. Carcinoma-like syndrome is a group of symptoms that are often seen in cancerous patients. These tumors are rare and slow to grow. Most carcinomas are found in the gastrointestinal tract. Carcinoma-like syndrome usually occurs in less than 10% of cancer-like patients, often after the spread of the tumor to the liver. The tumors of these patients will release too much serotonin, leading to diarrhea. Uncontrolled diarrhea syndrome includes weight loss, malnutrition, dehydration and electrolyte imbalance.

Note: Japan has no new drug approval in February.