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FDA Approves Caplacizumab-yhdp in Acquired Thrombotic Thrombocytopenic Purpura

Gina Columbus
Published: Wednesday, Feb 06, 2019

The FDA has approved the nanobody caplacizumab-yhdp (Cablivi) in combination with plasma exchange and immunosuppression for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), making it the first FDA-approved therapy indicated for this patient population.1

"The US approval of Cablivi provides a much-needed treatment option for people facing this challenging disease. There have been limited medicines available to treat aTTP until now," says Olivier Brandicourt, MD, chief executive officer of Sanofi, the manufacturer of the caplacizumab-yhdp. "Cablivi marks the first US approval in our newly formed rare blood disorders franchise, and we look forward to continuing to provide important medicines for people living with these very serious diseases."

References

  1. FDA approves Cablivi® (caplacizumab-yhdp), the first Nanobody®-based medicine, for adults with acquired thrombotic thrombocytopenic purpura (aTTP). Sanofi. Published February 6, 2019. https://bit.ly/2SdZuCG. Accessed February 6, 2019.
  2. Scully M, Cataland SP, Peyvandi F, et al. Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura. N Eng J Med. 2019;380:335-346. doi: 10.1056/NEJMoa1806311.

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