The Medicines Company expects to submit an NDA early next year to the FDA for its Carbavance (meropenem-vaborbactam). That’s on the heels of top-line pivotal data to treat patients with complicated urinary tract infections (cUTI) that demonstrated superiority as compared to another antibiotic, piperacillin-tazobactam.
The FDA has already designated Carbavance as a Qualified Infectious Disease Product (QIDP), as authorized under the GAIN Act, and it has been granted Fast Track status.
“The clinical microbiologic responses to Carbavance were among the highest of clinical trials recently conducted with new antimicrobial agents in complicated urinary tract infection,” said The Medicines Company VP and CMO of the Infectious Disease Group Jeff Loutit on a conference call about the data.
“Demonstration of superiority with Carbavance treatment of pip-tazo in the FDA primary endpoint, and the robust effects in other endpoints demonstrates the potential gains that we can make clinically in the treatment of gram-negative infections,” he added.
Patients were treated with a three-hour IV infusion given every 8 hours or piperacillin-tazobactam as a 30 minute IV infusion every 8 hours, with each given for up to 10 days. After at least 5 days of therapy, patients were transitioned to oral levofloxacin once they met predefined criteria.
The company anticipates that the data should be sufficient for submission to both the FDA and the EMA, since it met each of their pre-specified endpoints in complicated urinary tract infections (cUTI). It expects an EMA submission for the candidate in this indication will also come in 2017.
“Carbavance met the FDA per-specified non-inferiority margin and met criteria for a superiority of efficacy. It met EMA pre-specified non-inferiority margin of efficacy and demonstrated comparable safety and tolerability to piperacillin-tazobactam, which is widely acknowledged by physicians as a safe combination,” noted Loutit.
The candidate is designed to address gram-negative bacteria that produce new beta-lactamase enzymes. These are the main form of carbapenem-resistant Enterobacteriaceae (CRE). The candidate is also in another Phase III trial, TANGO 2, to treat serious infections due to CRE; the company expects to submit interim data from this trial to support an NDA.
The Medicines Company ($MDCO) acquired Carbavance in a 2013 deal to buy Rempex Pharmaceuticals for $140 million upfront along with $214 million in development and regulatory milestones and $120 million in commercial milestones.
Shares in The Medicine Company gained about 2% in early trading on the news--but the $2.4 billion company remains off about 9% for the year so far.
- here is the release
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