FDA Approvals Roundup: Sutab, Keytruda, Vimpat

Regulatory NewsRegulatory News
| 18 November 2020 | By Renee Matthews 

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approval
Sutab approved as tablet-form prep for colonoscopy
Sebela’s Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) has been approved as a tablet-form preparation for colonoscopy, providing patients with an alternative to liquid-based preparations.
Colonoscopy is considered the gold standard of screening for colorectal cancer. Adequate bowel preparation is crucial for ensuring the best possible visualization of polyps or abnormalities that may be present in the colorectal space.
The preparation’s approval was based on efficacy and safety findings from two randomized, single-blind, active-controlled pivotal trials. In all, 92% of patients who cleansed with Sutab achieved successful bowel cleansing and  92%-95% achieved successful cleansing in all segments of the colon, including the proximal colon. Sutab scored well on patient satisfaction as well. In one of the trials, 91% of patients said the study preparation was “easy to tolerable” to consume, and 78% they would want to use it again for a future colonoscopy. Sutab’s safety and effectiveness have not been demonstrated for pediatric patients.
Sutab was developed and will be marketed by Braintree Laboratories, a part of Sebela. Braintree also makes Suprep Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) in an oral solution formulation.
New indications
Keytruda gets expanded indication for recurrent advanced triple-negative breast cancer
Merck’s Keytruda (pembrolizumab) has received an expanded indication in combination with chemotherapy for treating locally recurrent, unresectable or metastatic triple-negative breast cancer (TNBC) in patients whose tumors express the programmed death-ligand 1 (PD-L1) protein, as determined by a companion diagnostic.
The agency also approved the PD-L1 IHC 22C3 pharmDx (Dako North America) assay for selecting patients with TNBC with a combined protein score of ≥10 to receive Keytruda.
The application was granted accelerated approval based on progression-free survival (PFS) findings in the KEYNOTE-355 study. Continued approval for the new indication will depend on further verification and description of the drug’s clinical benefit in confirmatory trials.
KEYNOTE-355, a multicenter, double-blind, randomized, placebo-controlled trial, included 882 patients from the indicated population who had not previously received chemotherapy in the metastatic setting. Median PFS was 9.7 months in the Keytruda-plus-chemotherapy patients, compared with 5.6 months in the placebo patients.
Keytruda was originally approved in 2014 for treating melanoma. In addition to its latest approval, it has also been approved for the treatment of renal cell carcinoma, cutaneous squamous cell carcinoma, and classical Hodgkin lymphoma, among others.
FDA used the assessment aid in its review.
Vimpat handed new approval for primary generalized tonic-clonic seizures in children
UCB’s Vimpat (lacosamide) CV has been approved as an adjunctive therapy for primary generalized tonic-clonic seizures (PGTCS) in children aged 4 years or older.
The intravenous formulation of the drug is now also approved for use in the same population. The drug was originally approved in 2008 as an add-on therapy for partial-onset seizures in adults with epilepsy. In 2014, it was approved as a monotherapy for adults, and in 2017, as monotherapy or adjunctive therapy for partial-onset seizures in patients aged 4 years or older. Until now, the injection was approved for use only in patients aged 17 years or older.
PGTCS is a type of seizure that occurs across both sides of the brain, causing patients to lose consciousness and experience severe, protracted convulsions.
Approval of Vimpat was supported by efficacy and safety findings from a phase 3, double-blind, randomized, placebo-controlled study of 242 patients who received Vimpat as an adjunctive treatment or placebo. Patients receiving Vimpat had a significantly lower risk of developing a second PGTCS during the 24-week treatment period, compared with those on placebo (55.3% vs. 33.37%, respectively; relative risk reduction, 45%; P = .001). Study drug patients had a significantly higher rate of freedom from PGTCS during the same period, compared with placebo patients (31.3% vs. 17.2%, P = .011).


© 2022 Regulatory Affairs Professionals Society.

Tags: FDA, US

Discover more of what matters to you

No taxonomy