FDA OKs New Drug Approvals for J&J and Amgen

By Patricia Van Arnum - DCAT Editorial Director

April 25, 2019

In tracking approvals of new molecular entities, Johnson & Johnson's Janssen Pharmaceutical gains FDA approval for Balversa (erdafitinib) for treating metastatic bladder cancer and Amgen gets the FDA nod for Evenity (romosozumab-aqqg) to treat osteoporosis.

J&J Gets FDA Nod For Bladder Cancer Drug

Janssen Pharmaceutical, part of Johnson & Johnson, has received US Food and Drug Administration accelerated approval for Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.

Balversa received an accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm Balversa’s clinical benefit, and the sponsor is conducting or plans to conduct these studies. Balversa was also granted breakthrough therapy designation.

The FDA also approved the therascreen FGFR RGQ RT-PCR Kit, developed by QIAGEN Manchester, Ltd., for use as a companion diagnostic with Balversa for this therapeutic indication.

Source: FDA

FDA Approves Amgen’s Osteoporosis Drug Evenity

The US Food and Drug Administration (FDA) has approved Amgen’s Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture).

The drug is indicated for women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies.

Evenity is a monoclonal antibody that blocks the effects of the protein sclerostin and works mainly by increasing new bone formation.

Source: FDA

FDA Approves Teva’s Generic Naloxone Nasal Spray for Opioid Overdoses

The US Food and Drug Administration (FDA) has granted final approval to Teva Pharmaceutical Industries of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a medication that can stop or reverse the effects of an opioid overdose.

The FDA tentatively approved this generic drug product in June 2018. Teva Pharmaceuticals USA Inc. now has received final FDA approval to market generic naloxone nasal spray in the US.

The FDA said it is also planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with a previously announced action to help facilitate an over-the-counter naloxone product.

Source: FDA