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EMA recommends extension of dalbavancin indication in children

AP22 1030 Xydalba2
  • Published: 16 Dec 2022
  • Xydalba® (dalbavancin) is the first and only long half-life antibiotic recommended in children for the management of ABSSSI (Acute Bacterial Skin and Skin Structure Infections)
  • Dalbavancin is a broad-spectrum antibiotic that can be administered with a single dosage (1,500 mg) and a 30-minute infusion, thus promoting a reduction in hospital length of stay, with positive implications for the medium- to long-term decrease in intrahospital infections and economic sustainability for national health services
  • Distinguished from older-generation antibiotics by its prolonged action against the majority of Staphylococcus aureus strains resistant to other currently available antimicrobials, it has 16-fold greater action against MRSA (Methicillin-Resistant Staphylococcus Aureus)

Angelini Pharma announced today that the European Commission (EC) has approved the extension of dalbavancin for the treatment of pediatric patients (3 months of age and older) with acute bacterial skin and soft tissue infections (ABSSSI). The EC approval follows the positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP), on October the 13th.

ABSSSI are a group of bacterial skin infections, with severity ranging from mild infections to life-threatening disease,1 and are associated with considerable morbidity and a heavy burden to healthcare systems.2 An estimated 70% of hospitalizations for skin infections in Europe were due to ABSSSI, of which over 10% of patients were infected with MRSA.2

Dalbavancin is distinguished from older generation antibiotics by its prolonged action against the majority of Staphylococcus aureus strains resistant to other currently available antimicrobials. Previous in-vitro studies have shown that dalbavancin is 16 times more effective against MRSA than other agents such as vancomycin and linezolid.3

In addition, it can be administered as a single infusion dose requiring only 30 minutes to complete, thus promoting a reduction in hospital length of stay, with positive implications for the medium- to long-term decrease in intrahospital infections and economic sustainability for national health services. 

"The EC's approval for extending the indication of dalbavancin for treatment in pediatric patients, who are among the most at risk of contracting infectious diseases that are still of great concern worldwide, is an important step forward in the treatment of children affected by skin infections. Dalbavancin is a molecule that is well known in terms of efficacy and safety in adults and now it will finally be available for children," said Agnese Cattaneo, Chief Medical Officer of Angelini Pharma. "Thanks to a constant investment in research, Angelini Pharma has been committed for decades to fighting infectious diseases with products for the treatment of acute infections, such as those affecting the urinary tract, skin infections and resistant myalgias, and to meet as much as possible the needs and therapeutic requirements of patients, in this case the youngest ones.”

The extension of dalbavancin’s indication – a next-generation bactericidal lipoglycopeptide, whose mechanism of action is to disrupt cell wall synthesis in susceptible bacteria4,5 – to the treatment of ABSSSI in children is based on the results of the interim report of a Phase III, multi-center, open-label, active‑controlled study designed to evaluate the efficacy and safety of dalbavancin administered to pediatric patients with ABSSSI from birth to 18 years of age or younger.

"Dalbavancin is an important treatment option for clinicians who require alternative antibiotics for the treatment of skin infections in children," said Professor Luisa Galli, Associate Professor of Pediatrics at the Department of Health Sciences, University of Florence. "Given the ever-increasing emergence of antibiotic resistance around the world, healthcare professionals need new drugs to combat life-threatening skin infections that also affect children."

About dalbavancin

Dalbavancin is a new generation lipoglycopeptide antibacterial (J01XA04), which interrupts cell wall synthesis in susceptible Gram-positive bacteria, approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The benefits of dalbavancin are its ability to act against important groups of Gram-positive bacteria, including strains of methicillin resistant Staphylococcus aureus (MRSA) and some Staphylococcus aureus with reduced susceptibility to glycopeptides, as well as pathogenic streptococci. In addition, it possesses a pharmacokinetic profile which allows once-weekly or single-shot intravenous infusion dosing. The most common side effects are nausea, diarrhea and headache.

Angelini Pharma licensed dalbavancin from Durata Therapeutics International B.V. in 2016. Following a series of acquisitions, Durata, a clinical development-stage pharmaceutical company focused on the treatment of infectious disease, now belongs to AbbVie, who is also the Marketing Authorization Holder (MAH) of dalbavancin in the EU. Via this licensing agreement, Angelini Pharma, as Local Representative of the MAH, commercializes dalbavancin in many European countries including Austria, the Czech Republic, Greece, Italy, Poland, Romania, Slovakia and Spain. Dalbavancin initially received EMA approval for ABSSSI in adults in February 2015, further to an application from Durata Therapeutics International B.V. On October 13th 2022, the CHMP granted a positive opinion for the extension of the indication of dalbavancin for the treatment of ABSSSI in children. Dalbavancin is also marketed in the U.S. by AbbVie under the trade name Dalvance®.

The detailed recommendations for the use of dalbavancin are described in the Summary of Product Characteristics (EU SmPC).

 

References 

  1. Stevens DL, et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the infectious diseases society of America. Clin Infect Dis. 2014;59(2):147–159
  2. Grossi et al. Skin infections in Europe: a retrospective study of incidence, patient characteristics and practice patterns. Int J Antimicrob Agents. 2022;60(3):106637
  3. Mendes, et al. Update on dalbavancin activity tested against Gram-positive clinical isolates responsible for documented skin and skin-structure infections in US and European hospitals (2011-13). Antimicrob. Chemother. 2016; 71(1):276–8
  4. Committee for Medicinal Products for Human Use (CHMP) Xydalba (2014). Disponibile all’indirizzo: https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-xydalba_en.pdf. Last accessed: December 2022
  5. Boucher, et al. Once-Weekly Dalbavancin versus Daily Conventional Therapy for Skin Infection. 2014; 370(23):2169–79