A one- or two-shot antibiotic has been launched in the UK for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
Cardiome's Xydalba (dalbavancin) is cleared for administration as either one 1500mg dose or as a two-dose regimen of 1000mg followed one week later by 500mg, each administered intravenously over 30 minutes.
The injection is a second-generation, semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone, designed to fight bacterial infections of the skin and of skin structures such as cellulitis, skin abscesses and wound infections, caused my bacteria such as methicillin resistant Staphylococcus aureus (MRSA).
Clinical trials showed the drug to be at least as effective as vancomycin or linezolid at curing infection. According to Phase III data, between 87 percent and 94 percent of patients treated with Xydalba were cured, compared with between 91 percent and 93 percent of patients treated with any of the two comparators.
"We are pleased that Xydalba is now available to our medical professionals in the UK," said Dr Kiran Bhirangi, Cardiome's head of Medical Affairs. "The single dose option provides the opportunity that the patient will get a full course of antibiotic therapy without the need to return to the hospital multiple times for follow-up dosing."
Just days ago the company said it was close to launching Xdalba in the UK having received an established price for the product from the Secretary of State for Health.
"The creation of an established price does not guarantee reimbursement in the UK, but it is a critical step in preparation for launch by allowing Cardiome to start negotiating with individual hospitals to gain formulary access for Xydalba," said Hugues Sachot, senior vice president Commercial at Cardiome, at the time.
In May 2016, Cardiome signed an exclusive license agreement with an affiliate of Allergan to commercialise the antibiotic in France, the UK, Germany, Belgium, Nordic nations, certain other European nations (not already partnered), various Middle Eastern nations and Canada.
According to Datamonitor, the UK ABSSSI hospital market is valued at around $74 million.