FDA Updates for the Week of Dec. 12, 2022


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.

FDA approves first gene therapy for bladder cancer.

The FDA has approved Adstiladrin (nadofaragene firadenovec-vncg) to treat adult patients with high-risk non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. It is indicated for patients who are resistant to Bacillus Calmette-Guérin (BCG), an immunotherapy that is used to treat patients with early-stage bladder cancer.

Non-muscle-invasive bladder cancer is a cancer that has grown through the lining of the bladder but hasn't yet invaded the muscle layer. This type of cancer is associated with high rates of recurrence and risk of metastatic cancer.

Developed by Ferring Pharmaceuticals, Adstiladrin is an adenoviral vector‑based gene therapy containing the gene interferon alfa-2b, administered by catheter into the bladder once every three months.

Ferring expects that Adstiladrin will be commercially available in the United States in the second half of 2023, following manufacturing capacity expansion.

FDA approves Fresenius Kabi’s Humira biosimilar.

The FDA has approved the Fresenius Kabi’s adalimumab biosimilar Idacio to treat patients with chronic autoimmune diseases. It references AbbVie’s Humira (adalimumab). Fresenius Kabi plans to launch the product in the United States in a self-administered prefilled syringe and a self-administered pre-filled pen (autoinjector) after July 2023. Idacio is a citrate-free formulation of adalimumab. Since its first launch in 2019, Idacio has been approved and commercialized in more 37 countries around the world.

This is the eighth Humira biosimilar to be approved and made available next year. Amgen’s Amjevita will be the first one launched in January. The others expected to launch in the second half of the year include: Organon's Hadlima, Boehringer Ingelheim’s Cyltezo, Coherus BioSciences’ Yusimry, Viatris’ Hulio, Sandoz’ Hyrimoz, and Pfizer’s Abrilada.

KRAS-targeted lung cancer drug carries $237,000 annual price tag.

The FDA has granted accelerated approval for Mirati Therapeutics’ Krazati (adagrasib) for KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). The wholesale acquisition cost for Krazati is $237,000 per year, or a monthly cost of $19,750 for 200 mg tablet/180 count bottle, Mirati Therapeutics said in a statement. The manufacturer said it would be available in the United States immediately.

Although KRAS G12C is the most common KRAS mutation in NSCLC, patients have had limited options to treat the condition, Mirati said in a news release.

The FDA also approved a companion diagnostic, Qiagen’s therascreen KRAS RGQ PCR kit to identify patients eligible for treatment with Krazati. This is the fourth approval for the diagnostic. It is already labeled for used in label for use in NSCLC and colorectal cancer.

FDA approves Iyuzeh to reduce intraocular pressure.

The FDA has approved the new drug application (NDA) of Thea Pharma’s Iyuzeh (latanoprost ophthalmic solution) to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Iyuzeh is a preservative-free formulation of latanoprost, the most prescribed prostaglandin F2α analogue. It does not need to be manufactured, distributed, or stored at refrigerated temperatures unlike some other competitive brand and generic latanoprost and prostaglandin products. Company executives said Iyuzeh will be available in the second half of 2023.

FDA extends review of Lynparza/abiraterone for prostate cancer.

The FDA has extended by three months the Prescription Drug User Fee Act (PDUFA) date for the pending supplemental new drug application (sNDA) for Lynparza (olaparib). The drug is being reviewed to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC) in combination with abiraterone and prednisone or prednisolone. The agency indicated it needed additional time for full review.

Lynparza is a first-in-class PARP inhibitor developed by Merck and AstraZeneca. It is the first targeted treatment to potentially exploit DNA damage response pathway deficiencies, such as BRCA mutations. Lynparza is approved in the United States for patients with homologous recombination repair (HRR) gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone. Other indications include advanced ovarian cancer, HER2-negative early and metastatic breast cancer, and metastatic pancreatic cancer.

Pfizer, BioNTech snag fast track for COVID-19-Flu vaccine combo.

The FDA granted Fast Track Designation to Pfizer and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19. The vaccine aims to help prevent two respiratory diseases with a single injection, the two pharma makers said in a news release.

The solution would be a “logical fit alongside Pfizer’s authorized standalone mRNA COVID-19 vaccine, prospective standalone mRNA influenza vaccine, and other authorized or investigational vaccines across Pfizer’s portfolio and pipeline targeting critical infectious diseases,” a Pfizer spokesperson said.

The companies began a phase 1 trial to evaluate the safety, immunogenicity, and optimal dose level of a combined vaccine candidate in November 2022. The trial will enroll 180 healthy volunteers and each patient will be followed for six months.

Soligenix submits NDA for novel therapy for cutaneous T-cell lymphoma.

Soligenix has submitted a new drug application (NDA) to the FDA for HyBryte (synthetic hypericin) to treat patients with early stage cutaneous T-cell lymphoma (CTCL). Cutaneous T-cell lymphoma is a rare type of cancer that begins in T cells, which causes the immune system to attack the skin. HyBryte is a novel photodynamic therapy. The active ingredient is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light about 24 hours later.

AbbVie submits sNDA for Linzess for children and adolescents.

AbbVie has submitted to the FDA a supplemental new drug application (sNDA) for Linzess (linaclotide) to treat children and adolescents 6 to 17 years of age with functional constipation (FC). Linzess is developed and marketed by AbbVie and Ironwood Pharmaceuticals in the United States and is currently indicated to treat adults with chronic idiopathic constipation (CIC) or irritable bowel syndrome with constipation (IBS-C).

Functional constipation in children is defined as a condition with hard, infrequent bowel movements that are often difficult or painful to pass. It is a common problem in children of all ages, with a worldwide prevalence ranging between 0.7% and 29.6%.

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