Taylor Tieden
for BioSpace
The FDA is looking at four events for the remainder of October, one of which is an advisory committee meeting for a dual SGLT inhibitor for use alongside insulin in type 1 diabetes and chronic kidney disease.
This month seems to be a relatively slow one for the FDA, which has only a handful of catalysts coming up, including target action dates for a KRAS inhibitor and a UTI drug.
Read below for more.
Amgen Seeks Colorectal Cancer Approval for Lumakras
By October 17, the FDA is expected to release its
decision
on
Amgen
’s application for Lumakras (sotorasib) in combination with Vectibix (panitumumab) for the treatment of metastatic colorectal cancer.
The application is backed by the CodeBreaK 300 study, which tested the combination regimen against the investigator’s choice of therapy. A total of 160 patients were enrolled into the study, according to
its clinicaltrials.gov page
, all of whom carried the
KRAS
G12C mutation. The FDA gave Amgen’s application its Priority Review designation.
In August 2023, Amgen announced that Lumakras plus Vectibix
aced the primary endpoint
in CodeBreak 300, demonstrating a significant improvement in progression-free survival versus current standard of care. Additional data from the study were reported at the 2024 American Society of Clinical Oncology annual meeting in June, showing a
trend toward better overall survival
in patients treated with Amgen’s drug combo.
Lumakras
is a small molecule inhibitor of G12C-mutated
KRAS
, which is involved in the hyperactive cell division seen in cancer. It keeps mutated
KRAS
in an inactive state and helps prevent unchecked tumor growth while also prompting cell death.
The drug was
first approved
for non-small cell lung cancer under the FDA’s accelerated pathway in May 2021, but its full approval was
denied in December 2023
, with the regulator asking for an additional confirmatory study.
Camurus Proposes Subcutaneous Octreotide for Acromegaly
Swedish biotech Camurus is seeking approval for its investigational subcutaneous injection of octreotide for the once-monthly treatment of acromegaly, a hormonal disorder that causes abnormal bone and tissue growth. The FDA has until October 21 to release its
verdict
.
Octreotide is a peptide drug that has long been approved for acromegaly. Bynfezia Pen (octreotide acetate), for instance, was approved for subcutaneous treatment in 1988 and is also indicated for other diseases, such as diarrhea associated with metastatic carcinoid tumors or vasoactive intestinal peptide tumors.
According to Bynfezia’s
label
, octreotide works by mimicking the effects of the natural hormone somatostatin, exerting a strong inhibitory effect on other hormones, such as glucagon and insulin. Octreotide also blocks the action of growth hormone, which in acromegaly is present in high amounts.
Camurus’ subcutaneous formulation of octreotide, dubbed CAM2029, allows for better exposure to the drug and enables a more convenient once-monthly dosing schedule. Bynfezia, by comparison, is given three times a day for acromegaly. CAM2029 also comes as a pre-filled injection pen to allow self-administration.
The drug application is backed by the Phase III ACROINNOVA 2 study, which enrolled 135 patients who either had biochemically controlled disease or who had uncontrolled disease but were on stable doses of standard-of-care therapy. Results showed that CAM2029 led to better biochemical control of acromegaly versus standard of care, alongside improvements in symptom burden and quality of life.
Iterum Advances Oral UTI Drug for Women
The FDA is reviewing Iterum Therapeutics’ New Drug Application (NDA) for sulopenem etzadroxil/probenecid, also called oral sulopenem, for the treatment of uncomplicated urinary tract infection (uUTI) in women. The regulator is expected to release its
verdict
by October 25.
Oral sulopenem is backed by findings from the Phase III REASSURE study. According to a
topline readout
in January 2024, oral sulopenem matched oral Augmentin (amoxicillin/clavulanate) in terms of overall response, the study’s primary endpoint. Additionally, overall success, which takes into account clinical and microbiological outcomes, was statistically better in the oral sulopenem group than in Augmentin comparators.
Last month, the FDA’s Antimicrobial Drugs Advisory Committee met to discuss Iterum’s application. While the panel of external experts was not asked to vote on any specific matter, Iterum
found the discussion to be encouraging
for oral sulopenem’s regulatory prospects.
The experts, said CEO Corey Fishman, “acknowledged oral sulopenem as an important treatment option for certain patients with uUTI and agree that the appropriate use of oral sulopenem by treating physicians is critical to limiting antimicrobial resistance.”
The FDA had
previously rejected
oral sulopenem in uUTI, noting in July 2021 that Iterum needed to provide additional clinical data to support an approval.
After Previous Rejection, Lexicon’s Insulin Adjunct to Face Adcomm
To close out the month, the FDA
will convene
its Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) On October 31 to discuss Lexicon Pharmaceuticals’ Zynquista (sotagliflozin), which the biotech is proposing as an adjunctive therapy to insulin to control blood glucose levels in patients with type 1 diabetes and chronic kidney disease (CKD).
Zynquista’s active ingredient sotagliflozin works by inhibiting the SGLT2 and SGLT1 proteins, which are involved in the absorption of glucose in the kidneys and gastrointestinal tract, respectively. Lexicon
first sought type 1 diabetes approval
for sotagliflozin in 2018, backing its application with data from the inTandem clinical program, which includes three Phase III trials with around 3,000 patients enrolled.
In January 2019, however, the EMDAC was
split
regarding sotagliflozin’s approvability, with half of the panelists voting against it, citing the risk of diabetic ketoacidosis and other safety issues. Months later, in March 2019, the FDA
rebuffed Lexicon’s regulatory bid
.
Lexicon appealed the FDA’s verdict, though this has since stalled. The biotech
refiled
its NDA in June 2024, with CEO Lonnel Coats at the time reiterating that the company is “confident in the benefit/risk pro sotagliflozon” for type 1 diabetes and CKD.
