Politics and Policy

ImmunityBio’s Anktiva is an antibody cytokine fusion protein approved to treat patients with non-muscle invasive bladder cancer.

Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.

Entyvio as an injection and subcutaneous formulations is approved to treat both Crohn’s and ulcerative colitis.

Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.

The vaccine combines the antigenic components of its two meningococcal vaccines: Bexsero and Menveo. The action date is Feb. 14, 2025.

Fasenra is now approved to treat patients aged 6 and older with eosinophilic asthma, a rare form of asthma.

The FDA is reviewing two novel therapies: a psychedelic-assisted therapy for PTSD with a target action date of Aug. 11, 2024, and therapy for schizophrenia that does not directly block dopamine receptors with an action date of Sept. 26, 2024.

The FDA is currently reviewing tarlatamab for small-cell lung cancer with a review date in June and datopotamab deruxtecan for non-small cell lung cancer with a review date in the fourth quarter.

FDA officials are looking for additional information about the infusion device used to deliver apomorphine.

The FDA is also considering a separate BLA for a 2 mL syringe. Bimzelx is already available to treat plaque psoriasis as a 1 ml syringe; a dose is two subcutaneous injections with a cost of $7,200 per syringe.

Zevtera was approved to treat Staphylococcus aureus bloodstream infections, acute bacterial skin and skin structure infections; and community-acquired bacterial pneumonia.

Fanapt is now approved to treat adults acute manic or mixed episodes associated with bipolar I disorder. It is also available to treat schizophrenia.

Voydeya was approved for patients with paroxysmal nocturnal hemoglobinuria rare, progressive blood disorder that results in the developed of abnormal blood cells that are missing important proteins.

Vemlidy is now approved to treat patients 6 years and older with chronic hepatitis B virus infection.

Vafseo, an oral therapy to treat patients with anemia due to chronic kidney, will be available in January 2025. About 40% of patients who could be treated with Vafseo have coverage through Medicare Advantage plans.

Sotatercept — now with the brand name Winrevair — will be available through specialty pharmacies by the end of April. The price of Winrevair is $14,000 per vial.

J&J’s Opsynvi is single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a PDE5 inhibitor. It will be priced on parity with Opsumit, which is also a J&J product to treat patients with pulmonary arterial hypertension.

FDA officials indicated that the confirmatory trial for odronextamab for patients with follicular lymphoma and diffuse large B-cell lymphoma should be under way before resubmission.

The full approval was based on the confirmatory phase 3 MIRASOL trial, which showed that Elahere resulted in a 33% reduction in risk of death and a 35% reduction in the risk of cancer progression.

Duvyzat is an oral nonsteroidal drug that works to reduce the inflammation and loss of muscle experienced by patients with Duchenne muscular dystrophy. It will be available in the third quarter of 2024.

Tryvio, an oral drug for those with uncontrolled hypertension, will be available in the second half of 2024. The list price has not yet to be determined.

The accelerated approval of Iclusig for patients with acute lymphoblastic leukemia and with the Philadelphia chromosome was based on a surrogate endpoint. Iclusig has a list price of $20,831 for 30 tablets.

Lenmeldy (atidarsagene autotemcel) is the first gene therapy to treat children with juvenile metachromatic leukodystrophy (MLD).

The FDA has assigned a goal date of Aug.13, 2024, for Lymphir to treat patients with relapsed or refractory cutaneous T-cell lymphoma.

Tevimbra will be available in the second half of this year and is indicated as a second-line treatment of patients with esophageal squamous cell carcinoma, which is an aggressive cancer.

Breyanzi is the first CAR-T therapy to treat adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Madrigal Pharmaceuticals is pricing Rezdiffra (resmetirom) at wholesale acquisition price of $47,400 per year.

Livmarli is now approved to treat the itching associated two different rare liver diseases: progressive familial intrahepatic cholestasis and Alagille syndrome.

The additional indication is for chhildren as young as 8 years of age with heterozygous familial hypercholesterolemia.

GA Depot is a once-monthly injection to treat patients with relapsing forms of multiple sclerosis. No information was provided for why the FDA issued a complete response letter.