Denise Myshko

Although not a common complication of hip, knee and other metal implants, the number of allergic reactions is growing, partly the number of joint replacements is growing, according to a presentation at the annual meeting of the American Academy of Dermatology. Nickel is the most common contact allergen.

The FDA has approved a novel nasal spray for migraine and a generic leukemia treatment. The agency has granted priority review to Leqembi for traditional approval but extended the review of hemophilia A gene therapy. Regulators have also assigned target dates for Voxzogo in young children with dwarfism, a skin infection gel, a nerve disorder drug and for Jardiance in children 10 to 17 with diabetes.

The FDA has approved Kevzara for an inflammatory rheumatic disease and Skyclarys, the first therapy for rare neuromuscular disease. The agency set an action date for Opdivo for melanoma indication. An advisory committee has supported Pfizer’s RSV vaccine, and Janssen has submitted an NDA for combo tablet for metastatic prostate cancer.

The FDA approved several new therapies this week, including a weekly hemophilia A treatment, an extended-release version of Austedo, and the first drug for geographic atrophy due to AMD, as well as an accelerated approval to Filspari for rare kidney disease. The agency also indicated it will hold an advisory committee meeting on Onpattro for heart failure indication, granted priority review for Pfizer’s RSV vaccine and for a life-threatening hereditary immune disease, and also set goal date for blurry vision therapy.

Disparities in access to pediatric eye care have increased over the past 15 years and are associated with lower socioeconomic status.

Starting with Avastin to treat patients with diabetic macular edema — and switching to Eylea if patients don’t have a response — could result in savings of more than $125 million.

Sedentary behavior has been linked with low-grade systemic inflammation, which could disrupt the ocular surface.

The FDA has approved two pediatric indications this week: Takhyzro for hereditary angioedema and Eylea for retinopathy of prematurity. The agency expanded the label of Cibinqo for atopic dermatitis in adolescents, and granted full approval to Jemperli for endometrial cancer. Additionally, the agency has set PDUFA dates for two drugs: reproxalap for dry eye and zuranolone for depression.

In 2022, 12 states have enacted 19 pieces of legislation that offer a variety of restrictions and requirements for pharmacy benefit managers (PBMs).

The FDA has approved two breast cancer therapies this week: Trodelvy to treat patients with HR+/HER2- breast cancer and Orserdu to treat patients with ER+, HER2-, ESR1-mutated disease. The agency also approved a novel therapy for CKD-related anemia and Tezspire in pre-filled pen.

The FDA approved a new drug for type 2 diabetes and a new BTK inhibitor for rare blood cancer while Keytruda got another indication in lung cancer. But Evusheld lost its EUA for COVID-19. The agency accepted an sNDA for Jardiance for CKD and officials said they plan to hold advisory committee meeting for Biogen’s ALS drug.

Scientists have created a lipid nanoparticle that was able to deliver mRNA to the retina, providing an opportunity for the development of additional gene therapies for the eye.

Researchers found that visual impairment is more prevalent among those who are older, Hispanic, non-White, and less educated and have lower incomes.

This week the FDA approved new indications for already available therapies, including Brukinsa for chronic lymphocytic leukemia and an accelerated approval for Tukysa for HER2-positive colorectal cancer, as well as an extended-release form of risperidone for schizophrenia. The agency also issued a complete response letter for Lilly's Alzheimer’s drug and accepted an application for a NASH drug.

Girls were more likely to develop dry eye after surgery, and nondominant eyes are more likely to develop postoperative dry eye.

The FDA has approved two medications: Rybelsus for first-line treatment of diabetes and asthma rescue combination medication. The agency has accepted an sNDA for Rexulti for Alzheimer’s agitation, and Eisai submits new Alzheimer’s drug for full approval.

The FDA ends the week with the approval of the Alzheimer’s medication lecanemab. Two other approvals include: Olpruva for urea cycle disorders and Wegovy for weight loss in teens. The agency has also accepted several applications, including Genentech’s second bispecific antibody, glofitamab, for blood cancer, UCB’s second application for generalized myasthenia gravis, and a therapy RSV prevention in infants. Two companies have submitted applications: Celltrion for a new formulation of infliximab and Orasis for blurry vision treatment.

In a busy week for FDA approvals, the agency cleared several first in class therapies: a treatment for HIV-1 and for follicular lymphoma. Other approvals include: Tymlos for osteoporosis in men; Vraylar for major depressive disorder; Cytalux to identify lung cancer during surgery. In COVID-19 news, the agency approved Actemra for hospitalized patients. The FDA has also accepted a sBLA for Padcev, Keytruda combo for urothelial cancer.

ICER analysts remain uncertain about using amyloid removal as a surrogate marker for clinical benefit in Alzheimer’s disease.

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.

In COVID-19 news, the FDA granted fast track designation to COVID-19-flu vaccine combo. The FDA has approved the first gene therapy for bladder cancer, an 8th biosimilar referencing Humira, granted accelerated approval for KRAS-mutated lung cancer therapy, and approved Iyuzeh to reduce intraocular pressure. The agency also extended review of Lynparza/abiraterone combination for prostate cancer. In addition, two companies have submitted applications: Soligenix for a novel therapy for cutaneous T-cell lymphoma and AbbVie for Linzess in children and adolescents.

This isn’t the first time pharmacy benefit managers (PBMs) have been ensnared in controversy. PBMs were first created in the 1960s to help insurance companies manage and administer claims for prescription drugs. Over time, they took on the roles of claims adjudication, rebate negotiation and benefit design.

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.

In COVID-19 news, the FDA has expanded the updated bivalent vaccines EUA to children. The FDA has requested athe removal of Pepaxto indication for multiple myeloma. Regulators have also accepted several applications for: Biogen’s Actemra biosimilar, Pfizer’s RSV vaccine, a resubmitted BLA for Fabry disease. Two companies — Janssen’s and Alnylam — have submitted new applications.

Seven of the 10 top selling drugs with high price increases lack the clinical evidence to justify those increases.

The APOE gene is known for its association in Alzheimer’s disease. Investigators are beginning to understand its role in age-related macular degeneration and other eye diseases.

In an umbrella review — a review of reviews — investigators found that so far, studies of ocular biomarkers to diagnose Alzheimer’s disease had important limitations. Longitudinal studies that use artificial intelligence could perhaps identify ocular biomarkers, the researchers suggest.

This week, the FDA made two approvals, the first-ever microbiota product and a second indication for Brexafemme, and issued a CRL for a therapy for brain metastasis from neuroblastoma. The regulatory agency also granted priority review for a Duchenne gene therapy, and accepted three applications: for a cutaneous T-cell lymphoma therapy, for an antibiotic for drug-resistant infections and Evkeeza for children with rare high cholesterol. Additionally, Genentech has withdrawn Tecentriq’s indication for bladder cancer and Aldeyra has submitted an NDA for the novel dry eye therapy reproxalap.

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.

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.