FDA Review: Alnylam, Cytokinetics, Eli Lilly and More

Jason Armond / Los Angeles Times via Getty Images

The FDA had a fairly quiet week, approving drugs, providing clearance, greenlighting clinical trials, and other regulatory activities for Alnylam, Eli Lilly, Cytokinetics, Prometheus, Owlet, and more. 

Here’s a look at the agency’s reported activities.

Oct. 6

Alnylam Pharmaceuticals’ Oxlumo (lumasiran) received an approval for an expanded indication to include advanced primary hyperoxaluria type 1 (PH1) patients with severe renal impairment, including patients on hemodialysis.

The FDA scheduled a Cardiovascular and Renal Drugs Advisory Committee meeting for Dec. 13 to discuss Cytokinetics’ NDA for omecamtiv mecarbil tablets to reduce the risk of cardiovascular death and heart failure events in patients with symptomatic chronic heart failure with reduced ejection fraction.

Eli Lilly received Fast Track designation for its tirzepatide to treat adults with obesity or overweight with weight-related comorbidities. 

Boston Cell Standards received 510(k) clearance for its IHControls panel (HER2/ER/PR) for evaluating breast cancers.

Owlet submitted a 510(k) premarket notification for a new prescription monitoring device for infants. The device uses pulse oximetry and is intended to be prescribed by doctors for in-home monitoring of babies.

Annovis Bio received the go-ahead for a Phase II/III trial of buntanetap in moderate Alzheimer’s.

Entera Bio concluded its Type C meeting and agreement with the FDA that a single Phase III placebo-controlled trial could support an NDA of EB613 under the 505(b)(2) regulatory pathway. The FDA also agreed that Total Hip Bone Mineral Density (BMD) could be the primary endpoint of the registrational trial in post-menopausal osteoporosis patients.

Kiromic BioPharma received validating written feedback from the FDA regarding its Type B Pre-IND meeting request over its Deltacel development strategy. Deltacel/KB-GDT is being developed for non-small cell lung cancer.

Oct. 5

Transcenta Holding’s TST004 received IND clearance to run a clinical trial for the treatment of IgA nephropathy.

Oct. 4

Multi Radiance Medical received FDA clearance for its MRM FibroLux laser therapy to treat pain associated with fibromyalgia. 

Oct. 3

PDS Biotechnology reported a successful End-of-Phase II meeting with the FDA for PDS0101 in combination with Merck’s Keytruda for treatment of unresectable, recurrent/metastatic human papilloma virus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC). PDS will move into a registrational trial ahead of the originally planned schedule.

Prometheus Biosciences received the greenlight to initiate a Phase I single ascending dose/multiple ascending dose (SAD/MAD) trial for PRA052 in healthy volunteers. The drug is being developed to treat ulcerative colitis.

Kira Pharmaceuticals received clearance to launch a Phase II trial of KP104 in systemic lupus erythematosus associated thrombotic microangiopathy.

Kite announced the FDA approved its retroviral vector (RVV) manufacturing facility in Oceanside, Calif.

Eagle Pharmaceuticals’ ENA-001 was granted Orphan Drug Designation for treatment of Apnea of Prematurity.

Poxel received Orphan Drug Designation for PXL770 for patients with autosomal-dominant polycystic kidney disease.

Seneca Therapeutics received clearance to initiate a Phase I/II trial using Seneca Valley Virus (SVV-001) in combination with a checkpoint inhibitor in patients that are TEM8 positive and SVV-001 permissive with neuroendocrine tumors of neuroendocrine carcinomas.

Sept. 30

Taiho Oncology and Taiho Pharmaceutical Co.’s Lytgobi was approved by the FDA for treatment of adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or other rearrangements.