FDA approves Genentech’s drug for rare disease affecting optic nerves, spinal cord

The FDA has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a certain antibody — patients who are anti-aquaporin-4 or AQP4 antibody-positive.

NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Enspryng, made by Genentech, is the third approved treatment for the disorder.

In patients with NMOSD, the immune system mistakenly attacks healthy cells and proteins, most often those in the optic nerves and spinal cord. This typically results in attacks of optic neuritis, which causes eye pain and vision loss. Approximately 50% of patients with NMOSD have permanent visual impairment and paralysis caused by NMOSD attacks. Estimates vary, but NMOSD is thought to affect approximately 4,000 to 8,000 Americans.

NMOSD may be associated with antibodies that bind to a protein called aquaporin-4 (AQP4). Binding of the anti-AQP4 antib…

Read more
  • 0

Novartis, Alexion charged with FPCA violations


Novartis (NYSE:NVS) and Alexion Pharmaceuticals (NSDQ:ALXN) were charged with violations of the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act (FCPA).

The Securities & Exchange Commission (SEC) announced that the pharmaceutical companies both committed violations and both agreed to pay millions of dollars to settle the charges. Novartis settled to pay over $112 million and Alexion agreed to pay more than $21 million.

Basel, Switzerland-based Novartis, with its local subsidiaries or affiliates, or former subsidiary Alcon, was found to have engaged in schemes to make improper payments or to provide benefits to public and private healthcare providers in South Korea, Vietnam and Greece in exchange for prescribing or using Novartis or Alcon products.

The SEC says the schemes took place between 2012 and 2016 and were known among certain managers of the subsidiaries or affiliates. According t…

Read more
  • 0