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FDA Approvals Roundup: Tepotinib, Posimir, Gocovri

Posted 03 February 2021 | By Renee Matthews 

FDA Approvals Roundup: Tepotinib, Posimir, Gocovri

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approvals
Tepotinib gets accelerated approval for metastatic NSCLC
Serono’s Tepmetko (tepotinib) has been granted accelerated approval for treating adults with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations.
The kinase inhibitor was approved based on efficacy findings from the multicenter, nonrandomized, open-label VISION trial in 152 adult patients from the indicated population. Patients were either treatment naïve (n = 69) or had been previously treated (n = 83) and they all received the study drug daily until disease progression or unacceptable toxicity. Overall response rate was 43% for both  treatment-naïve and previously treated patients, with median durations of response of 10.8 and 11.1 months, respectively.
Continued approval for this indication may be contingent on verification of clinical benefit in follow-up confirmatory trials. The review used the real-time oncology review and the assessment aid. It was conducted in collaboration with Project Orbis partners, Health Canada, Therapeutic Goods Administration, and Swissmedic.
Posimir gets the go-ahead for postsurgical pain after arthroscopic subacromial decompression
Durect’s Posimir (bupivacaine solution) has been approved as a nonopioid, sustained-release local analgesic for adults with postsurgical pain after arthroscopic subacromial decompression.
The bupivacaine solution for infiltration uses a sucrose acetate isobutyrate extended-release (SABER) platform technology for continuous delivery of the therapy for up to 72 hours.

Posimir’s approval was based on positive data from a randomized, multicenter, assessor-blinded, placebo-controlled trial in patients undergoing arthroscopic subacromial decompression. Patients receiving Posimir showed statistically significant improvements in pain intensity and reduction in the amount of opioid rescue analgesia they needed during the 72 hours after surgery. Mean pain intensity in treated patients was reduced by 1.3 points on a scale of 0-10 (20%; P = .01), compared with placebo patients. In addition, study drug patients showed a 67% reduction in IV morphine-equivalent rescue opioid use, from a median of 12 mg in the placebo group to 4 mg in the Posimir group (P = .01).
Durect has to conduct two follow-up postmarketing studies under the terms of the approval.
New indications
Gocovri nabs extended indication as add-on therapy for Parkinson’s OFF episodes
Adamas’s Gocovri (amantadine extended release capsules) has been granted a new indication as an adjunctive therapy to Sinemet (levodopa/carbidopa) in patients with Parkinson’s disease who experience OFF episodes.
Patients with Parkinson’s disease receiving levodopa-based therapy may have a recurrence of stiffness, rigidity, and tremors, known as OFF episodes, between medication doses.
Gocovri was approved based on findings from two placebo-controlled, Phase 3 studies showing the study drug significantly reduced OFF time and dyskinesia, resulting in an increase in good ON time in patients receiving a levodopa-based therapy. In addition, findings from the Phase 3, open-label EASE LID-2 study demonstrated sustained efficacy for at least 2 years in Gocovri-treated patients.
Gocovri was approved in 2017 for treating dyskinesia in patients with Parkinson’s disease receiving a levodopa-based therapy.
Plegridy okayed for IM administration in patients with multiple sclerosis
Biogen’s Plegridy (peginterferon beta-1a) has been approved for intramuscular (IM) administration in  patients with relapsing forms of multiple sclerosis (MS). The therapy was first approved in 2014 as subcutaneous (SC) injection for the indication.
Approval of the IM administration was based on an evaluation of data on bioequivalence and adverse reactions related to IM and SC administration of Plegridy in healthy volunteers. Bioequivalence between the two routes of administration were confirmed, and data also demonstrated that patients in the IM administration group had fewer injection site reactions, compared with those in the SC administration group (14.4% and 32.1%, respectively). Safety profiles were similar for the two groups.
Rapivab use extended to include babies with uncomplicated influenza
BioCryst’s Rapivab (peramivir injection) has received an expanded indication for acute uncomplicated influenza in patients aged 6 months or older who have been symptomatic for no more than two days.
Rapivab was approved in 2014 for treating acute uncomplicated influenza in patients aged or older. In 2017 it was indicated for children aged two years or older.

Tags: FDA, US

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