Vonjo Granted Approval to Treat Rare Cancer

Vonjo™ (pacritinib) has received U.S. FDA approval to treat intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis in adults who have a platelet count below 50 × 109/L.

  • Vonjo is a novel oral kinase inhibitor that acts against enzymes in the body that may contribute to myelofibrosis, a rare bone marrow cancer. In myelofibrosis, scar tissue replaces healthy bone marrow and interferes with production of red blood cells, white blood cells, and platelets.
  • Recommended dosing is two 100mg capsules taken twice daily by
  • CTI BioPharma, the manufacturer, has announced that Vonjo will be available at a wholesale acquisition cost (WAC) of $19,500 per month.

Jardiance Receives New Heart Failure Indication

February 24, 2022 – Jardiance® (empagliflozin – Boehringer Ingelheim) is now indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults who have heart failure.

  • Initially FDA approved in 2014, Jardiance is also indicated as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes, and to reduce the risk of cardiovascular death in adults who have type 2 diabetes and established cardiovascular disease.
  • Recommended dosing is 10mg once daily in the morning. For adults who have type 2 diabetes and require additional glycemic control, the dose can be increased to 25mg per day.

 

 

 

First Restasis Generic Approved for Dry Eye

The U.S. FDA has approved Mylan’s generic for Restasis® (cyclosporine ophthalmic emulsion) 0.05% single-use vials.

  • Like Restasis, the generic is indicated to increase tear production when that production is believed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye).
  • Recommended dosing is one drop in each eye twice daily, approximately 12 hours apart.
  • Brand name Restasis is manufactured by Allergan and first received FDA approval in 2002. It has a wholesale acquisition cost (WAC) of $645.63 per month. Mylan’s generic is available at a WAC of $588.82 per month.