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# FDA Approves Ablynx Drug for Rare Blood Clotting
- URL: https://www.fdaweb.com/fda-approves-ablynx-drug-for-rare-blood-clotting/
- Published: 2019-02-06T12:00:00.000Z
- Updated: 2026-09-15T01:00:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143314

FDA has approved a Ablynx BLA for Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for treating adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting. Patients with aTTP develop extensive blood clots in the small blood vessels throughout the body, an [FDA release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630851.htm?ref=fdaweb.com) says. “These clots can cut off oxygen and blood supply to the major organs and cause strokes and heart attacks that may lead to brain damage or death,” it explains. “Patients can develop aTTP because of conditions such as cancer, HIV, pregnancy, lupus or infections, or after having surgery, bone marrow transplantation or chemotherapy.”

Approval is based on clinical trial efficacy data from 145 patients who were randomized to receive either Cablivi or a placebo. Data demonstrated that platelet counts improved faster among patients treated with Cablivi compared to placebo. Cablivi treatment also resulted in a lower total number of patients with either aTTP-related death and recurrence of aTTP during the treatment period, or at least one treatment-emergent major thrombotic event, the agency says.

Common side effects reported by patients in clinical trials were bleeding of the nose or gums and headache. The prescribing information for Cablivi includes a warning to advise health care providers and patients about the risk of severe bleeding. “Health care providers are advised to monitor patients closely for bleeding when administering Cablivi to patients who currently take anticoagulants,” FDA says.