FDA Approvals Roundup: Semglee, Saphnelo, Uptravi
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).FDA Approvals Roundup: Semglee, Saphnelo, Uptravi
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approvals
Semglee okayed as first Interchangeable biosimilar insulin product for diabetes
Mylan’s Semglee (insulin glargine-yfgn) has been approved as the first interchangeable biosimilar insulin product for improving glycemic control in adults and children with type 1 diabetes and in adults with type 2 diabetes.
Semglee (insulin glargine-yfgn) is also the first interchangeable biosimilar product approved in the US. It is biosimilar to, and interchangeable with, its reference product, Lantus (insulin glargine). Semglee’s interchangeability status means that pharmacy-level substitution for Lantus, without prescriber intervention, is now permitted.
Approval of Semglee was based on evidence showing the biosimilar had high similarity with Lantus and was not clinically different from the reference product. The evidence also showed Semglee can be expected to produce the same clinical result as Lantus and that the safety and efficacy risks are not greater than those of Lantus.
Semglee had been approved in 2020 under the 505(b)(2) pathway as a biosimilar to Lantus.
Saphnelo approved for moderate to severe systemic lupus erythematosus
AstraZeneca’s Saphnelo (anifrolumab-fnia injection) has been approved as a therapy for moderate to severe systemic lupus erythematosus (SLE) in adults receiving standard therapy. It is the only new medicine for SLE in more than 10 years.
The approval was based on efficacy and safety findings from the Saphnelo clinical development program, including two TULIP Phase 3 trials and the MUSE Phase 2 trial. In these trials, more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems and achieved sustained reduction in oral corticosteroid use compared with those receiving placebo, with both groups receiving standard therapy.
New indications
Uptravi approved for IV use in pulmonary arterial hypertension
Janssen’s Uptravi (selexipag) has received approval for an intravenous (IV) injection formulation for treating pulmonary arterial hypertension (PAH) to delay disease progression and reduce the risk of hospitalization in adults who are temporarily not able to take the tablet form of the therapy.
Approval of the new drug application for IV Uptravi was based on findings from a prospective, multicenter, open-label, single-sequence, cross-over Phase 3 study in 20 patients who were temporarily switched between oral and IV Uptravi. Findings showed the switch between tablets and IV injection was well tolerated, with no unexpected safety findings.
Uptravi tablets were approved in 2015 for the same patient population.
Botox expanded label includes new muscles in treatment of upper-limb spasticity
AbbVie’s Botox (onabotulinumtoxinA) has received a label expansion that includes eight new muscles in the treatment of upper-limb spasticity in adults. The label now also includes use of ultrasound as a muscle localization technique in adult spasticity.
Botox was first approved in 1989 for adults with the eye muscle disorders blepharospasm and strabismus. It has subsequently been approved for other indications, including chronic migraine, overactive bladder, and pediatric spasticity.
Nucala gets new indication for use in adults with chronic rhinosinusitis with nasal polyps
GlaxoSmithKline’s Nucala (mepolizumab) has received a new indication as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps in adults aged 18 years or older who have an inadequate response to nasal corticosteroids. It the first anti-interleukin-5 biologic to be approved for this patient population in the US.
The approval for this indication was based on findings from the Phase 3 double-blind, parallel group SYNAPSE study in 400 patients from the indicated population randomized to receive Nucala or placebo. There was a 57% reduction in the proportion of patients who needed surgery among the patients receiving Nucala compared with those receiving placebo. A lower proportion of patients receiving Nucala used systemic corticosteroids during the 52-week treatment period, compared with the placebo patients.
Nucala was first approved in 2015 for severe eosinophilic asthma in adults and children and received subsequent approvals for other eosinophilic-driven diseases.
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