FDA Updates for Week of July 3, 2023


This week, the FDA granted full approval to the Alzheimer’s drug Leqembi, set an action for review of zolbetuximab to treat gastric cancers and rejected Amneal’s new drug application (NDA) Parkinson’s disease treatment.

CMS Expands Leqembi Coverage After FDA’s Full Approval

The Centers for Medicare & Medicaid Services announced that broader Medicare coverage is now available for the Alzheimer’s disease treatment Leqembi (lecanemab-irmb) after the FDA granted traditional approval. Now that the FDA has granted traditional approval, a CMS-facilitated registry is open for clinicians.

Leqembi had been granted accelerated approval in January 2023 and launched with a list price of $26,500 a year. CMS indicated that now that there is full approval, patients with original Medicare will pay a 20% coinsurance once they meet their Part B deductible. CMS has provided a new HCPCS claim code (Leqembi J0174) and requests that claims be submitted after July 25, 2023.

Leqembi, developed by Eisai and Biogen, is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in Alzheimer’s disease. The full approval was based on data from the phase 3 confirmatory Clarity AD clinical trial. In this study, Leqembi reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months.

FDA Sets Action Date for Zolbetuximab for Stomach Cancers

The FDA has accepted and granted priority review for Astellas’ biologics license application (BLA) for zolbetuximab as a first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

In the United States, it is estimated that 26,500 people will be diagnosed with gastric cancer and 11,130 will die from the disease in 2023. These cancers are often diagnosed in the advanced or metastatic stage. The five-year relative survival rate for patients at the metastatic stage is 6.6%.

Zolbetuximab is a first-in-class therapy for advanced gastric and gastroesophageal cancers. The target action date is Jan. 12, 2024. Zolbetuximab targets and binds to Claudin 18.2 (CLDN18.2), a transmembrane protein. Transmembrane proteins are involved in signal transduction, transport, and protein trafficking, and a study published last year indicated these proteins may contribute to the spread of cancer. Zolbetuximab acts by binding to CLDN18.2 on the cancer cell surface of gastric epithelial cells, which then induces cancer cell death by activating two distinct immune system pathways.

FDA Rejects Amneal’s Application for Novel Parkinson’s Therapy

The FDA has issued a complete response letter (CRL) for Amneal’s new drug application (NDA) for IPX203 for the treatment of Parkinson’s disease. The FDA is asking for additional pharmacokinetic data of carbidopa, one of the drugs in IPX203. Pharmacokinetic data provides information about how the drug is adsorbed, distributed, metabolized and excreted from the body.

Parkinson’s disease has become the fastest growing neurological disorder worldwide, with about 1 million patients diagnosed in United States. It is a progressive disorder of the central nervous system that affects dopamine-producing neurons in the brain that affect movement.

IPX203 is an oral formulation of carbidopa/levodopa extended-release capsules. The product contains extended-release beads that consist of levodopa, coated with a sustained release polymer, to allow for slow release of the drug. Additionally, this formulation contains immediate-release granules that consist of carbidopa and levodopa, with a disintegrant polymer to allow for rapid dissolution.

The FDA’s CRL for IPX203 indicated that although an adequate scientific bridge was established for the safety of one ingredient, levodopa, based on pharmacokinetic studies, it was not adequately established for the other ingredient, carbidopa (CD), and FDA has requested additional information. The letter did not identify any issues with respect to the efficacy or manufacturing of IPX203.

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