Biologics

Dupixent COPD sBLA May Face Review Delay

Regeneron may be facing an approval delay on its supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The company said in a 5/2 earnings call that FDA recently requested sub-population breakdowns from the Phase 3 BOREAS and NOTUS trials, which may require a three-month review extension. “Our analyses across these requested patient subgroups indicate a consistent and clinically meaningful reduction in COPD exacerbations,” the company said.

In February, FDA accepted for priority review the supplemental BLA and set a 6/27 user fee review action target date. Regeneron says the submission is based on data from the Phase 3 COPD clinical research program evaluating the efficacy and safety of Dupixent in adults who were current or former smokers with uncontrolled COPD with evidence of Type 2 inflammation. “The primary endpoint was met in both trials (BOREAS, NOTUS), showing Dupixent significantly reduced moderate or severe acute COPD exacerbations by 30% and 34% respectively, compared to placebo,” it says. In both trials, Dupixent reportedly improved lung function compared to placebo, with improvements sustained at 52 weeks.

Safety-related results in both trials were generally consistent with the known safety profile of Dupixent in its approved indications, the company says. “Adverse events more commonly observed with Dupixent compared to placebo in either trial were back pain, Covid-19, diarrhea, headache and nasopharyngitis,” it adds.

Monoclonal antibody Dupixent works by inhibiting the signaling of the IL-4 and IL-13 pathways, according to the company. It’s currently approved for treating atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and prurigo nodularis.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome