Merck recently ad it will voluntarily withdraw the US fast-track approval indication for Keytruda (pembrolizumab) for certain patients with gastric cancer or gastroesophageal junction adenocarcinoma whose tumors express PD-L1, who have seen their disease progress after at least two processing lines. The decision follows April 29 audience of the FDA’s Oncology Drugs Advisory Committee, where the panel recommended not to continue with the indication. The decision does not affect the other indications of Keytruda.

FDA Acting Commissioner calls for review of Aduhelm’s approval. Janet Woodcock, MD, acting commissioner of the FDA, asked an inspector general investigator to review Aduhelm’s approval process.

She said she had confidence in the integrity of the staff and the review process.

“However, concerns continue to be raised regarding contacts between Biogen and FDA officials during the review process, including some that may have taken place outside of the formal correspondence process,” he said. -she said in a press release. letter which was posted on Twitter on Friday afternoon. “To the extent that these concerns could undermine public confidence in the FDA’s decision, I believe it is essential that the events in question be reviewed by an independent body such as the Office of Inspector General to determine whether interactions that occurred between Biogen and FDA review staff did not comply with FDA policies and procedures.

She also mentioned on Twitter that it is important that there is transparency around the decision-making process. She said an independent assessment would help ensure confidence in the integrity of the FDA.

FDA Approves Updated Label for Controversial Treatment of Alzheimer’s Disease. Biogen and Eisai have ad that the FDA has approved updated prescribing information for Aduhelm (aducanumab-avwa) to specify its use in patients with mild Alzheimer’s disease.

The Indications and Use section of the Label now states that “Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild stage dementia of the disease, the population in which treatment was initiated in the trials. clinics. There are no safety or efficacy data on the initiation of treatment at earlier or later stages of the disease than those that have been studied. This indication is approved as part of an accelerated approval based on the reduction in beta-amyloid plaques seen in patients treated with ADUHELM. Continued approval for this indication may depend on verification of clinical benefit in the confirmatory trial (s). “

Alfred Sandrock, Jr., MD, Ph.D., head of research and development at Biogen, said in a statement: “Based on our ongoing conversations with prescribing physicians, the FDA and patient advocates , we have submitted this label update in an effort to further clarify the patient population that was studied in the three Aduhelm clinical trials that supported approval. We are committed to continuing to listen to the needs of the community as clinical practice adapts to this important, first-rate treatment option.

The FDA had approved therapy in June 2021, although an advisory committee in November 2020 recommended not to approve it. FDA officials said in a declaration therapy is primarily a treatment directed against the underlying pathophysiology of Alzheimer’s disease, the presence of beta-amyloid plaques in the brain.

Padcev obtains full approval and a new indication in urothelial cancer. Astellas Pharma and Seagen ad the FDA has granted regular approval to Padcev (enfortumab vedotin-ejfv) in the United States and has approved a new indication for adult patients with locally advanced or metastatic urothelial cancer who are not eligible for chemotherapy containing cisplatin and who have already received one or more previous lines of treatment.

In 2019, the FDA granted accelerated approval for Padcev for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 / L1 inhibitor and prior platinum-containing chemotherapy (neoadjuvant). or after (adjuvant) surgery, or in the context of locally advanced or metastatic urothelial cancer. The move from fast track to regular approval and label expansion was based on two Supplemental Biologics License (sBLA) applications reviewed under the Oncology Real-Time Review Pilot Program ( RTOR).

Bayer gets FDA green light for therapy that reduces heart and kidney complications. The FDA has approved Kerendia (finerenone) tablets from Bayer Healthcare for reducing the risk of decline in kidney function, kidney failure, cardiovascular death, non-fatal heart attacks and hospitalization for heart failure in adults with kidney failure chronic associated with type 2 diabetes.

Kerendia is a selective nonsteroidal mineralocorticoid (MR) receptor antagonist. By blocking overactivation of RM, a key factor in the progression of chronic kidney disease, therapy works on a path largely overlooked by existing treatments.

Kerendia’s approval is based on the positive results of the pivotal Phase III study FIDELIO-DKD, which has been published in the New England Journal of Medicine in October 2020. The FDA granted the priority review designation in January 2021.

“There is a great unmet medical need for early intervention to prevent further target organ damage and premature death by slowing the rate of decline in patients’ renal function as well as reducing cardiovascular risk”, principal investigator George L. Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, mentionned in a report.

FDA issues full response letter for teplizumab. Despite an advisory committee recommendation for approval, the FDA did not approve what would have been the first disease-modifying treatment for type 1 diabetes. The agency reported that a single low-dose pharmacokinetic / pharmacodynamic (PK / PD) transition study in healthy volunteers to compare a commercial product planned with a drug product derived from a drug substance manufactured for historical clinical trials had failed to show PK comparability.

Provention Bio expects that additional relevant PK / PD data will be, or will be, collected from a PK / PD substudy in patients receiving 12 days of treatment in the Phase 3 PROTECT trial in course in newly diagnosed T1D patients later this trimester. These data will be analyzed by independent, unblinded third parties to maintain the integrity of this placebo-controlled trial.

In the CRL, the FDA cited several additional product quality considerations, which company officials say have either been addressed in amendments already submitted to the BLA or may be addressed in the short term.

Amgen Submits Biologic Asthma Treatment Request. The FDA has accepted Amgen Biologics License Application (BLA) and Priority Review of Tezepelumab for the Treatment of Patients with Severe Uncontrolled Asthma. Tezepelumab is developed by Amgen in collaboration with AstraZeneca.

The Prescription Drug User Fee Act (PDUFA) deadline for an FDA decision is in the first quarter of 2022.

Tezepelumab is a human monoclonal antibody that blocks thymic stromal lymphopoietin, an epithelial cell-derived cytokine involved in asthma.

The BLA was based on the results of the PATHFINDER clinical trial program, including the results of the pivotal phase 3 NAVIGATOR trial. Researchers in the NAVIGATOR study found that patients with severe, uncontrolled asthma who received tezepelumab had fewer exacerbations and better lung function, better asthma control, and related quality of life. health than those who received a placebo. The results were published May 13, 2021, in the New England Journal of Medicine.

Novartis resubmits a request for inclisiran. Novartis has resubmitted its new drug application for inclisiran to treat hyperlipidemia in adults who have high low-density lipoprotein (LDL-C) cholesterol.

In December 2020, the FDA Posted a full response letter for inclisiran due to issues with a third party manufacturing facility. In its new submission, Novartis indicated that it was listing its own site in Schaftenau, Austria, as the site for manufacturing the finished product. Novartis has indicated that the transfer of the manufacture of inclisiran to Austria is planned and launched in 2020, before the receipt of the CRL.

The FDA has not raised any concerns regarding the efficacy or safety of inclisiran.