Emblaveo Approved for Complicated Intra-Abdominal Infections
On Feb. 7, 2025, the US Food and Drug Administration (FDA) approved Emblaveo™ (aztreonam and avibactam – AbbVie), in combination with metronidazole, for the treatment of adults who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Gram-negative bacterial infections represent a significant public health threat due to their ability to develop resistance to antimicrobial therapies, which could lead to over 39 million deaths worldwide by 2050. The FDA has prioritized treatments for antimicrobial resistance since if left unaddressed, minor infections could become life-threatening. Emblaveo is the first monobactam antibiotic, aztreonam, and β-lactamase inhibitor, avibactam, combination antibiotic therapy to treat antimicrobial resistance among Gram-negative bacteria. Avibactam protects aztreonam from a type of enzyme that causes bacteria to become resistant, therefore restoring its antibacterial activity. Approval is based on limited clinical safety and efficacy data, including prior findings on aztreonam for cIAI. The phase III REVISIT trial showed a clinical cure rate with Emblaveo for patients with cIAI of 76.4%, compared to 74% in standard of care, meropenem ± colistin comparator group. Safety findings were consistent with the known safety profile of aztreonam monotherapy. The recommended dose is based on an individual’s creatinine clearance and consists of a loading and maintenance dose given intravenously (IV) every six to 12 hours for five to 14 days. Emblaveo is expected to be available in the third quarter of 2025, and cost information is not available at this time. Full prescribing information may be found here.
Generic to Bosentan tablets for Oral Suspension Approved
On Feb. 5, 2025, Lupin and Natco Pharma received FDA approval of bosentan tablets for oral suspension, 32mg, a generic equivalent of Tracleer® tablets for oral suspension originally developed by Actelion Pharmaceuticals. An endothelin-receptor antagonist that lowers pulmonary vascular resistance (PVR) and mean pulmonary arterial pressure, bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) in pediatric patients aged three years and older with idiopathic or congenital PAH to improve PVR and potentially improve exercise ability. Bosentan tablets for oral suspension are dosed based on weight for patients 12 years of age or younger and are to be dispersed in a minimal amount of water immediately before administration twice daily. Natco is the first to file for this product and, therefore, eligible for 180 days of exclusivity. According to IQVIA from December 2024, the reference drug Tracleer had an estimated annual sales of $11 million in the US. Prescribing information will be available on the Drugs@FDA drug database at www.fda.gov
New Formulation for Evrysdi
The FDA approved Genentech’s Evrysdi® (risdiplam) 5mg tablet for people living with spinal muscular atrophy (SMA) on Feb. 12, 2025. Initially approved in 2020 as an oral solution, the survival motor neuron 2 (SMN2) splicing modifier is a non-invasive disease modifying treatment for SMA. Studies showed bioequivalence between the oral solution and tablet, meaning that they will offer the same efficacy and safety. The tablet is approved for people two years of age or older who weigh more than 44 pounds and can be either swallowed whole or dispersed in water. The oral solution will remain available. The cost is not known at this time; however, tablets are expected to be available in the coming weeks. Updated prescribing information may be found here.
Adcetris Gets a New Indication
On Feb. 11, 2025, the FDA approved Adcetris® (brentuximab vedotin – Seagen/Pfizer) in combination with lenalidomide and rituximab for adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy. Adcetris is a CD30 directed antibody-drug conjugate initially approved in 2011 to treat adult patients with relapsed or refractory Hodgkin lymphoma as an IV infusion and holds several other lymphoma indications. The ECHELON-3 trial demonstrated a statistically significant overall survival (OS) improvement with a median OS of 13.8 months in the treatment arm and 8.5 months in the placebo arm, as well as statistically significant improvements in progression free survival and objective response rate. The recommended brentuximab vedotin dose is 1.2mg/kg up to a maximum of 120mg in combination with lenalidomide and rituximab administered every three weeks until disease progression or unacceptable toxicity. Here is the updated prescribing information.
Izervay Receives Extended Approval for Geographic Atrophy
Astellas Pharma’s Izervay™ (avacincaptad pegol intravitreal solution) received a label expansion on Feb. 12, 2025, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). AMD progression results in marked thinning and/or atrophy of retinal tissue, and GA leads to further irreversible loss of vision in these patients. Izervay inhibits C5 complement protein-mediated inflammatory and membrane attack complex (MAC) activities that play a role in atrophy, yielding therapeutic benefits in both dry and wet AMD; however, it does not restore lost vision. Initially approved in 2023 for a duration of 12 months, Izervay is administered once monthly at a dose of 2mg (0.1mL) per eye in a sterile setting by a specialized eye care professional. It is now approved without a limitation on the duration of dosing. The phase III trial, GATHER2, showed that Izervay continued to reduce the rate of GA lesion growth in patients with GA secondary to AMD through two years compared to placebo control. Complete prescribing information may be found here.
FDA Approves Evolysse Dermal Filler
A press release dated Feb. 13, 2025, announced the FDA approval of Evolysse™ Form and Evolysse Smooth injectable hyaluronic acid gels (22mg/mL of hyaluronic acid with 3mg/mL lidocaine hydrochloride) by Evolus for dermal and subdermal injections to correct moderate to severe dynamic facial wrinkles and folds (such as nasolabial folds) in adults 22 years and older. Evolysse uses Cold-X™ technology by Symatese that preserves the natural structure of the hyaluronic acid molecule for more natural-looking, long-lasting results. When compared in a head-to-head trial with Restylane-L® (hyaluronic acid with 0.3% lidocaine – Galderma), Evolysse showed statistical superiority in nasolabial fold severity change from baseline at six and nine months despite 20% more Restylane-L being used. The cost is not yet known; however, the launch is expected in the second quarter of 2025, with Evolysse Sculpt launching in 2026 and Evolysse Lips in 2027. Directions for use and patient labeling can be found here.