Melinta Therapeutics nabs FDA nod for more convenient rework of antibiotic Orbactiv, a former Eli Lilly candidate
As pressure rises to address the superbug crisis, Melinta Therapeutics says it now has a more convenient option to treat those with antibiotic-resistant skin infections.
Melinta got the OK for a new-and-improved formulation of its antibiotic oritavancin in acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of Gram-positive microorganisms, including MRSA, the company announced on Monday. The drug, marketed as Kimyrsa, can be administered over one hour as opposed to Melinta’s earlier Orbactiv, which takes three.
“We have responded to the requests of the medical community to provide an oritavancin product with a shorter infusion time,” CEO Christine Ann Miller said in a statement. “We believe that with the approval of KIMYRSA and product availability this summer, physicians and patients will now have a compelling new one-dose alternative to the current standard of multi-dose regimens for ABSSSI.”
Oritavancin’s long journey to approval, beginning in Eli Lilly’s pipeline, is representative of the state of affairs in antibiotics, a high-risk field from which Big Pharma retreated years ago. Many antibiotics fail in development, while others wither on the vine due to a lack of available funding. And for the ones that do make it to market, it’s an uphill battle against currently existing options and cheap generics.
Lilly sold the worldwide rights to oritavancin to InterMune in 2001. Four years later, InterMune sold the drug to Targanta Therapeutics, which was on the hunt for “critically needed” antibiotics to treat antibiotic-resistant infections. In 2008, though, the FDA sent Targanta back to the clinic, issuing it a CRL for oritavancin in complicated skin and skin structure infections.
The following year, The Medicines Company lined up a $42 million deal to buy out Targanta and the Phase III drug.
“We believe that oritavancin can become an important anti-infective for serious infections involving difficult-to-treat bacteria in difficult-to-treat hospitalized patients,” the company announced. “Many of those critically ill patients are the same patients treated with our existing products.”
The FDA approved oritavancin in 2014 for ABSSSIs caused by susceptible Gram-positive bacteria, based on two trials dubbed SOLO I and SOLO II. The SOLO trials compared oritavancin to vancomycin, another Lilly original that’s now in the hands of ANI Pharmaceuticals. The studies showed that one 1,200 mg dose of oritavancin worked just as well as seven to 10 days of twice-daily vancomycin treatments, according to Melinta.
In 2017, Melinta executed a $270 million deal to buy out The Medicines Company’s infectious disease unit — including oritavancin.
In addition to the SOLO trials, the FDA based its latest approval for oritavancin on an open-label pharmacokinetics study, which compared a one-hour Kimyrsa treatment to a three-hour Orbactiv treatment.
“Single-dose, long-acting antibiotics, such as KIMYRSA, may be especially beneficial for patients who lack the support or resources to adhere to multiple intravenous administrations,” Andrew Dold, an infectious disease doctor in the Greater Atlanta region, said in a statement.