Denise Myshko

The FDA has approved a $3.5 million hemophilia B gene therapy and warned about Prolia in patients with kidney disease. The agency accepted for priority review two BLAs: for a dengue vaccine and for epcoritamab for large B-cell lymphoma. Additionally, GSK has pulled Blenrep from the U.S. market at the request of the FDA.

Hemgenix is the first one-time gene therapy treatment for adults with hemophilia B. It will have a list price of $3.5 million.

Formulary placement is crucial to the commercial success of newly approved products, so Acrutis put out a press release last week announcing that Express Scripts had put Zoryve (roflumilast), the company's PDE4 inhibitor cream for plaque psoriasis, on its formulary.

In a busy week, the FDA approved the first drug to delay diabetes, a second interchangeable Lantus biosimilar, and an alternate dosing schedule for Rylaze. The agency also granted accelerated approval of a novel ovarian cancer therapy, updated the target date for pegcetacoplan NDA review, and proposed prescription-to-OTC naloxone. In addition, an advisory committee supported the use of Xphozah in CKD.

OptumRx will offer Amjevita and two other biosimilars alongside Humira. OptumRx is the first large PBM to make public its plans for the seven Humira biosimilars that may come on the market next year.

Tzield addresses the underlying cause of the disease, where the immune system destroys the insulin producing cells in the pancreas. It will be available by the end of the year with a wholesale acquisition cost of $13,850 per vial.

OptumRx will offer Amjevita and two other biosimilars alongside Humira. OptumRx is the first PBM to make public its plans for the seven Humira biosimilars that could be introduced in 2023.

If approved, Xphozah will be the first phosphate absorption inhibitor for adults with chronic kidney disease who are on dialysis. An FDA decision is expected within 30 days.

OptumRx now requires prior authorization for 16 products, including 11 that are used to treat patients with diabetes.

The FDA approved several new therapies for cancers, including the combination of Imfinzi and Imjudo to treat lung cancer, Libtayo for second indication in lung cancer, and Adcetris for younger patients with Hodgkin lymphoma. In COVID-19 news, the agency issued an EUA for Kineret for hospitalized, but indicated bebtelovimab does not neutralize new omicron subvariants. The regulatory agency also accepted NDAs for a Parkinson’s disease therapy and for a therapy used for stem cell mobilization.

A 10-day implementation has given the team at Abarca Health the opportunity to challenge how they manage implementations in general.

Snezana Mahon, Pharm.D., Transcarent’s chief operating officer, discusses the company’s efforts to provide a seamless and interconnected pharmacy ecosystem.

The regulatory agency has added the risk of rare skin infections to the warnings and precautions section of the labeling for amoxicillin products.

The greatest reductions were seen in girls who were vaccinated when they were adolescents, with up to 73% reduction in cervical pre-cancerous lesions.

The FDA has approved a hepatitis B therapy for adolescents and an oral MEK inhibitor to treat blood cancers. The regulatory agency has granted priority review for an adult RSV vaccine but extended the review for a Pompe disease therapy. Additionally, CytoDyn has withdrawn its BLA for an HIV therapy.

Expanding pharmacist prescriber authority for HIV PrEP medications significantly increased PrEP use.

NIH researchers have created a 3D map of DNA within human retina cells and identified new gene variants that could be risk factors for age-related macular degeneration and glaucoma.

Wendy Barnes and Mark Campbell of RxBenefits discuss the company’s survey, which finds employers are curious about solutions to manage both specialty drug spend and the potential volatility that comes with employees who may be diagnosed with cancer and other high-dollar conditions.

A bioengineered corneal implant made with collagen from pig’s skin could be an alternative to human transplants for those with keratoconus, a rare condition that can lead to blurry vision and blindness.

Mikkael A. Sekeres, M.D., University of Miami Health System, discusses his latest book Drugs and the FDA and the use of accelerated approvals based on surrogate endpoints.

For patients with dry eyes, a cross-study comparison finds Tyrvaya may produce more natural tears than Xiidra.

A study of Oregon pharmacies finds there is significant disparities in reimbursement between the pharmacies, particularly in already disadvantaged communities.

The FDA approved two new novel cancer treatments: a bispecific antibody for multiple myeloma and a regimen of two drugs for liver cancer. The agency also granted priority review to two therapies. One is a novel therapy for C. difficile and the other is for a acute myeloid leukemia drug. The FDA has postponed an advisory committee meeting for an OTC birth control pill and accepted an NDA for new dry eye therapy. Additionally, Genmab submitted applications for a bispecific therapy for large B-cell lymphoma.

Renee Dua, M.D., chief strategy officer at Renee, discusses the digital health assistant and its subscription-based services for generic drugs.

One of the drivers of a lowered payer satisfaction is the public perception of PBMs, said Morgan Lee, Ph.D., of PSG.

In COVID-19 news, the FDA issued an EUA for Novavax booster. The agency has extended review time for new ALS therapy and accepted a supplemental NDA for Camzyos. Additionlly, the FDA granted six months pediatric exclusivity for Eylea.

Most of the brands that have been removed fall into the categories of hormonal therapies, pain and inflammatory conditions or skin conditions or high blood pressure/heart medications.

In COVID-19 news, the FDA has authorized updated boosters for younger children. The FDA also approved an at-home heart failure therapy, but issued a CRL for a Parkinson’s therapy. The agency has assigned PDUFDA dates for several BLA, including a hemophilia A gene therapy and Eylea for retinopathy in premature infants. Regulators have also announced an Adderall shortage. Additionally, a nonprofit company has begun the application process for OTC version of naloxone.

The Amgen Biosimilars Trend Report found that competition is lowering prices of biosimilars but the largest PBMs are inconsistent in their management of these products.

Regence implemented a preferred infliximab biosimilar strategy and was able to achieve more than 90% adoption.