Among the top safety stories this year are Genentech’s warning to Ocrevus label, FDA’s update to GnRH agonists, a study about JAK-inhibitor side effects, FDA’s warning about Prolia in kidney disease and safety issues related to the potential Alzheimer’s disease drug lecanemab.
Among the top-read FDA approval stories include the fast-acting Auvelity to treat major depressive disorder; an extended use for Mirena IUD; the first generic of Symbicort for asthma; Camzyos, a first-in-class treatment for obstructive hypertrophic cardiomyopathy; and Imbruvica’s expanded indication for children with chronic graft versus host disease.
Lunsumio is Genentech’s first approved T-cell engaging bispecific antibody and targets CD20 on the surface of B cells and CD3 on the surface of T cells.
Drug coverage decisions and new offerings from OptumRx, Caremark, Cigna and Wellcare made the list of the top-read drug coverage news in 2022.
Lenacapavir, now with the brand name Sunlenca, is a twice a year therapy for adult patients with multi-drug resistant HIV. It has a list price of $42,250 for the first year.
ICER analysts remain uncertain about using amyloid removal as a surrogate marker for clinical benefit in Alzheimer’s disease.
The combination includes an antibody-drug conjugate with an immunotherapy to treat patients with advanced bladder cancer. The PDUFA action date is April 21, 2023.
Rezlidhia is an oral, small molecule inhibitor of mutated IDH1 that was approved by the FDA to treat patients with relapsed or refractory acute myeloid leukemia.
Testing of the blood pressure medication revealed nitrosamine levels that were above acceptable limits.
Actemra is the first FDA-approved monoclonal antibody to treat hospitalized adults with COVID-19. The EUA for use of Actemra in children remains in place.
The monoclonal antibodies that treat patients with multiple sclerosis would have to be priced more than 50% lower to meet the common standards of cost-effectiveness, according to the Institute for Clinical and Economic Review.
Researchers modeling the cost-effectiveness of chimeric antigen receptor T-cell therapy (CAR-T) therapy and antibody conjugate found that they fell short.
Tymlos is already available to treat postmenopausal women with osteoporosis.
Lilly’s first-in-class medicine that activates both the GLP-1 and GIP receptors, Mounjaro, is the latest to be included on the FDA’s drug shortages list because of high demand.
This is the fourth indication for Vraylar, a dopamine and serotonin partial agonist that can now be used as an adjunctive therapy in patients with major depressive disorder.
Cytalux, approved in November 2021 for identifying ovarian cancer lesions, is now approved to spot lung cancer during surgery.
Smaller and midsize pharmacy benefit managers are taking on Optum Rx, CVS Caremark and Express Scripts. They say they have better technology and are more transparent about their pricing.
If approved, Linzess would be the first prescription therapy for functional constipation in children and adolescents 6 to 17 years of age.
Adstiladrin offers an alternative to bladder removal surgery for patients who are at high risk of recurrence and metastatic cancer.
A decision is anticipated in early January about which of the now eight Humira biosimilars will be included.
Prescryptive will offer a subscription-based program for employers that aims to provide a more predictable benefit for companies and their employees.
Iyuzeh is a preservative-free formulation of latanoprost and doesn’t need to be stored at refrigerated temperatures. It will be available in the second half of 2023.
HyBryte is a photodynamic therapy. The active ingredient, synthetic hypericin, is topically applied to skin lesions that is taken up by the malignant T-cells and activated by visible light.
This is the eighth biosimilar to reference the blockbuster rheumatoid arthritis drug Humira that will launch in 2023.
The agency has extended the review time by three months for Lynparza in combination with abiraterone and prednisone or prednisolone.
The Medicare Part D Senior Savings Model — a CMS effort to test $35 copays for insulin — led to lowered total costs for beneficiaries.
