FDA Updates for Week of April of 11, 2022

FDA issues EUA for first COVID-19 breath test.

The FDA has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.

Developed by the device company InspectIR Systems, the COVID-19 Breathalyzer test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage, the FDA said in a news release.

The test can provide results in less than three minutes

FDA okays third biosimilar of Avastin.

The FDA has approved the Amneal Pharmaceuticals’ biologics license application (BLA) for bevacizumab-maly, a biosimilar referencing Genentech’s Avastin. The product will be marketed under the name Alymsys.

Alymsys is a vascular endothelial growth factor inhibitor used in oncology. It is approved to treat metastatic colorectal cancer, non-squamous small cell lung cancer, recurrent gliobastoma, renal cell carcinoma, recurrent or metastatic cervical cancer, and epithelial ovarian cancer.

Alymsys was developed in collaboration with mAbxience. This marks the second of three biosimilars approvals Amneal expects to receive this year in oncology. Alymsys was approved by the European Medicines Agency (EMA) in February 2021.

Earlier this year, Amneal received approval of Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen. Ameal’s pegfilgrastim biosimilar referencing Neulasta is currently under review by the FDA.

The FDA extends review of REGEN-COV.

The FDA has extended by three months its review of the biologics license application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and a preventive medication for some people.

Regeneron has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review. The FDA considers the submission of these additional data to be a major amendment to the BLA and has provided a new target action date of July 13, 2022. The FDA has not requested any new studies.

REGEN-COV contains two monoclonal antibodies that are designed to block infection of SARS-CoV-2. It first became available in November 2020 under an emergency use authorization, but in January 2022 the FDA limited the EUA in the areas where the omicron variant of the virus was circulating saying the treatment was not effective against this variant. Currently, REGEN-COV is not currently authorized in the United States.

FDA clears first Elcys generic.

Even while Eton Pharmaceuticals is involved in a legal battle with Exela Pharma Sciences, the FDA cleared Eton’s generic for Exela’s cysteine hydrochloride (Elcys). Cysteine is used as an additive to meet nutritional needs of infants.

Eton was granted 180 days of generic exclusivity as a result of being the first ANDA submitted against the reference product. The 180-day exclusivity period will begin when Eton begins commercialization of the product.

The current market for cysteine injection is more than $50 million annually, according to IQVIA, Eton said in a news release.

Eton has been battling Exela since 2019 regarding the validity of Exela’s cysteine patents. A trial was held in March 2022, and Eton expects a decision from the judge in the third quarter of 2022.

Aeglea submits BLA for pegzilarginase for rare metabolic disease.

Aeglea BioTherapeutics has submitted a biologics license application (BLA) to the FDA for pegzilarginase for the treatment of arginase 1 deficiency (ARG1-D) and has requested priority review.

Pegzilarginase is a recombinant human arginase 1 enzyme that normalizes the elevated levels of the amino acid arginine in patients with ARG1-D, a rare, progressive disease characterized by high levels of arginine. Arginase is one of six enzymes that play a role in the breakdown and removal of nitrogen from the body. The lack of this enzyme results in accumulation of ammonia in the blood and arginine in the blood and cerebrospinal fluid.

People living with ARG1-D experience severe spasticity-related mobility limitations, seizures, developmental delay, intellectual disability, and early mortality.

FDA accepts resubmitted BLA for Rolontis.

The FDA has accepted the resubmitted biologics license application (BLA) for Rolontis (eflapegrastim). Developed by Spectrum Pharmaceuticals, Rolontis is a long-acting granulocyte colony-stimulating factor (G-CSF) to decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 9, 2022.

In August 2021, the FDA issued a complete response letter, citing deficiencies related to manufacturing. Spectrum executives said they have addressed the manufacturing deficiencies. The FDA has indicated that a reinspection of the drug substance manufacturing facility in South Korea will be required.