Voquezna is a potassium-competitive acid blocker, which has a mechanism similar to proton pump inhibitors but with a more rapid action. It will be available in December and has a list price of $650 for a 30-count bottle.
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Express Scripts has also included the heart failure drug Inpefa on its Medicare formularies.
Amgen’s Wezlana is approved to treat multiple inflammatory diseases. It is expected to launch no later than Jan. 1, 2025
If approved, mavorixafor would be the first therapy for WHIM syndrome, an ultra-rare disease that can cause recurrent lung infections, papillomavirus-related warts, and an increased risk of developing certain types of cancer. The PDUFA date is April 30, 2024.
A poster from AMCP Nexus quantified tends in biosimilar coverage within Tufts Medical Center, finding that payer coverage of these products has increased but individual preferences among payers still varies.
The Humira biosimilar Yuflyma will be available through CarePartners specialty pharmacy business, which has 10 million plan members.
Loqtorzi is indicated in combination with chemotherapy for first-line treatment and as monotherapy for patients with disease progression on or after platinum containing chemotherapy.
Agamree is a novel corticosteroid that will be available in the first quarter of 2024.
Based on reports from post-marketing experience, Spravato’s warnings and precautions section now includes the risk of respiratory depression.
Mirikizumab — now with the brand name — Omvoh has a list price of $9,593 per month for the IV formulation and $10,360 per subcutaneous administration.
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The mean lag time between FDA approval and insurance coverage for 89 cancer drugs ranged from 2.3 months to 8.2 months. But cancer drugs approved more recently were more likely to have shorter coverage lags.
In total, 11 lots of three different products have been recalled because of silicone found in retained samples.
N-803 — with the brand name Anktiva — plus the Bacillus Calmette-Guérin vaccine is being reviewed by the FDA to treat non-muscle-invasive bladder cancer. The goal date is April 23, 2023.
In new data, 60% of the patients with early stage Alzheimer’s disease and who have low levels of the protein tau achieved cognitive improvement when treated with Leqembi.
Akebia has resubmitted its NDA for vadadustat with postmarketing safety data from Japan, where it has been on the market for more than three years. The new review date is March 27, 2024.
Tibsovo is also approved to treat patients with IDH1-mutant acute myeloid leukemia and bile duct cancer.
Byooviz was approved as the first biosimilar to Lucentis and launched with a list price of $1,130 per single-use vial.
The FDA is requesting additional efficacy data to support an approval for patients with chronic spontaneous urticaria; results of an ongoing study are expected late next year.
Zymfentra is a subcutaneous version of infliximab.
Voxzogo is now approved for all ages in children with achondroplasia, the most common form of dwarfism.
Patients taking Mounjaro after a lifestyle intervention saw a weight reduction of almost 20%.
The increase is close to inflation and wage growth but much steeper than the atypically small increase in 2022.
Researchers in this review suggest clinical trials of biosimilars include switching studies to assess the pharmacokinetics of the biosimilar candidate.
Whether Opill (norgestrel) truly broadens access to daily contraception will depend on Medicaid coverage, requirements under the ACA and pharmacist prescribing.
Velsipity is the second oral S1P receptor modulator approved by the FDA to treat patients with moderate-to-severe ulcerative colitis. The wholesale acquisition cost is $6,164 for a 30-day supply.
Researchers identified age and insurance type as significant factors in viral suppression in patient with HIV because of their impact on patient adherence.
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