Formulary Watch

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.

Tymlos is already available to treat postmenopausal women with osteoporosis.

Cytalux, approved in November 2021 for identifying ovarian cancer lesions, is now approved to spot lung cancer during surgery.

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.

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.

A phase 3 study demonstrated that Onpattro improved functional capacity, health status and quality of life compared with placebo in this patient population.

The acceptance of Biogen’s application follows regulator’s acceptance of an application by Fresenius Kabi for another Actemra biosimilar.

Talquetamab is a bispecific antibody that targets both CD3 on T cells and GPRC5D, which is overexpressed on myeloma cells.

The EmsanaRx Plus program is connecting employers to the discounted drugs offered through Mark Cuban Cost Plus Drug Company. The program will be available beginning March 1, 2023

If approved the vaccine, RSVpreF, would be available for people 60 years of age and older. The Prescription Drug User Fee Act goal date for a decision is in May 2023.

A Prescription Drug User Fee Act action date for pegunigalsidase alfa is set for May 9, 2023.

SUL-DUR is a targeted antibiotic designed to treat serious drug-resistant infections. The target PDUFA date is May 29, 2023, and the FDA plans to hold an advisory committee meeting to discuss this application.

Brexafemme is a non-azole oral antifungal now approved to both treat and prevent recurrent yeast infections in women.

Exela Pharma is recalling an additional 14 lots of sodium bicarbonate injection because of a broken vial.

If approved, Evkeeza would be the first treatment to help children as young as 5 years old control high LDL cholesterol caused by homozygous familial hypercholesterolemia. The FDA target action date is March 30, 2023.

If approved, reproxalap would be the first inhibitor of RASP, which contributes to ocular inflammation and changes in tear lipid composition.

If approved, SRP-9001 (delandistrogene moxeparvovec) would be the first gene therapy for Duchenne. The FDA action date is May 29, 2023.

An advisory committee had voted against poziotinib to treat patients with non-small cell lung cancer with HER2 exon 20 insertion mutations.

Tzield addresses the underlying cause of the disease, where the immune system destroys the insulin producing cells in the pancreas. It is administered by intravenous infusion once daily for 14 consecutive days.

An FDA decision on Takeda’s dengue vaccine TAK-003 is expected within six months.

An FDA review has found that Prolia can result in low calcium levels in the blood in patients with advanced kidney disease and can lead to hospitalization and death.

A confirmatory trial in patients with relapsed or refractory multiple myeloma did not meet its primary endpoint of progression-free survival.

If approved, epcoritamab would be the first bispecific antibody to treat adult patients with relapsed/refractory large B-cell lymphoma. The Prescription Drug User Fee Act date is May 21, 2023.

Appellis had submitted updated data for the pegcetacoplan in age-related macular degeneration, which is considered a major amendment to the NDA. The new PDUFA date is Feb. 26, 2023.

Rylaze’s dosing options provide sustained asparaginase activity throughout the entire course of treatment for adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.