FDA Updates for the Week of March 20, 2023


FDA approvals this week include: novel treatment for invasive candidiasis, an accelerated approval to Zynyz for Merkel cell carcinoma, the high-concentration Humira biosimilar Hyrimoz, and extension of Evkeeza’s indication to include young children. The agency also issued two complete responses this week: for Incyte’s extended-release Jakafi and for AbbVie’s Parkinson’s therapy.

Hyrimoz, a high-concentration Humira biosimilar, approved by FDA.

The FDA has approved a citrate-free, high-concentration formulation (HCF) of Hyrimoz, the Humira (adalimumab) biosimilar from Sandoz. The biosimilar is approved as a 100 mg/mL injection to treat the 7 indications covered by the reference product, Humira: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.

FDA had already approved a low-concentration formulation of Hyrimoz back in 2018. Sandoz will launch both versions on July 1, 2021.

The citrate-free, HCF of Humira currently has the most market share. The HCF means patients have to inject a smaller volume of the drug, while the citrate-free formulation causes less pain at the injection site.

FDA grants accelerated approval to Zynyz for Merkel cell carcinoma.

The FDA has issued an accelerated approval to Incyte’s Zynyz (retifanlimab-dlwr) to treat adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). MCC is a rare skin cancer that tends to grow quickly and has a high rate of metastatic disease, leading to a poor prognosis. The estimated five-year overall survival rate is 14% in patients with Merkel cell carcinoma who present with distant metastatic disease. MCC impacts less than 1 per 100,000 people in the United States, but incidence rates are rapidly rising, especially in adults over the age of 65.

Zynyz is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1). A spokesperson for Incyte said Zynyx will be priced comparable to other agents in the class currently available in the marketplace. The list price for Merck’s Keytruda (pembrolizumab), which is a PD-1 inhibitor that is also approved to treat patients with advanced Merkel cell carcinoma, is $21,367.04 when given every six weeks. Incyte provides patient access and financial assistance through IncyteCARES

FDA clears first new treatment for invasive candidiasis in 10 years.

The FDA has cleared Cidara Therapeutics and Melinta Therapeutics’ Rezzayo (rezafungin for injection) to treat candidemia and invasive candidiasis in adults with limited or no alternative treatment options. It is the first new treatment option approved for patients with candidemia and invasive candidiasis in more than a decade, the two companies said.

Invasive candidiasis is a serious infection that can affect the blood, heart, brain, eyes, bones or other parts of the body. A Candida bloodstream infection, also called candidemia, is the most common form of invasive candidiasis, and can result in long hospital stays, according to the CDC.

Rezzayo is a novel once-weekly echinocandin antifungal. It will be available to healthcare professionals and patients this summer, so the company anticipates announcing the list price of Rezzayo closer to that time, a Melinta spokesperson said.

FDA extends Evkeeza indication to include young children.

The FDA has extended the approval of Regeneron’s Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH). HoFH is an ultra-rare genetic condition characterized by extremely high levels of LDL-C and, until now, treatment options to help reduce LDL-C in younger children have been limited. It affects about 1,300 people in the United States and is the most severe form of familial hypercholesterolemia. Those living with HoFH are at risk for premature atherosclerotic disease and cardiac events even in their teenage years.

Evkeeza is a monoclonal antibody that blocks the function of angiopoietin-like 3 (ANGPTL3) that is now indicated for children as young as 5 years old to control high levels of low-density lipoprotein cholesterol. Evkeeza was initially approved in 2021 as an adjunct to other lipid-lowering therapies in those aged 12 years and older.

Evkeeza has a wholesale acquisition cost of $11,661 for single-dose vial for 345 mg/2.3 mL and $40,560 for a single-dose vial for 1200mg/8 mL. A spokesperson said the actual cost will vary as this is a weight-based medication and has a competitive price that is in line with other ultra-orphan biologics.

FDA rejects NDA for extended-release Jakafi.

The FDA has issued a complete response letter for the new drug application (NDA) for Incyte’s Jakafi (ruxolitinib) extended-release tablets. The product was being reviewed for once-daily use to treat patients with certain types of myelofibrosis, polycythemia vera and graft-versus-host disease.

Regulatory officials said the data met the objective of bioequivalence parameters but identified additional requirements for approval. Incyte intends to meet with the FDA to determine appropriate next steps.

FDA wants more information about AbbVie’s Parkinson’s therapy.

The FDA has issued a complete response letter (CRL) for AbbVie’s new drug application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) to treat adults with Parkinson’s disease with motor fluctuations. Parkinson’s disease, a progressive and chronic neurological disorder resulting from the loss of dopamine-producing brain cells, which primarily manifests with tremor, muscle rigidity, slowness of movement and difficulty with balance.

ABBV-951 is a combination of foscarbidopa and foslevodopa, which are prodrugs of carbidopa and levodopa, which are common therapies used in the treatment of Parkinson’s disease. The new therapy is designed to provide 24-hour, continuous subcutaneous delivery of oral immediate-release carbidopa/levodopa.

In its letter, the FDA requested additional information about the device (pump) as part of the NDA review. The CRL does not request that AbbVie conduct additional efficacy and safety trials related to the drug.

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