Lilly's rival to Novo's new Awiqli insulin gets FDA approval
The FDA has approved Eli Lilly's once-weekly basal insulin product Onswik for adults with type 2 diabetes, setting up a market tussle with Novo over its recently launched Awiqli.
Onswik (insulin efsitora) – like Awiqli (insulin icodec) – is a long-acting insulin analogue that can be self-administered using an autoinjector and reduces the number of injections needed by T2D patients from more than 300 a year to just 52.
It has been approved by the FDA six months after the US regulator gave the green light to Awiqli as the first weekly basal insulin in the market, after turning down Novo's first attempt to win approval last year over manufacturing issues.
Ahead of its approval, analysts at Clarivate highlighted Awiqli as a future blockbuster, putting its annual sales potential at $4.7 billion in G7 markets (Canada, France, Germany, Italy, Japan, the UK, and the US) by 2030, although, other market observers are less optimistic, with consensus sales projections of around $1.2 billion.
Either way, Lilly has now crashed that party, adding to the fierce competitive pressure it is already applying to Novo's GLP-1-based diabetes and obesity medicines.
The US is the fourth region to approve Onswik after Europe, Japan, and Mexico, based on data from the QWINT clinical trials programme showing that it was non-inferior to daily basal insulins, like Sanofi's Lantus (insulin glargine) or Novo Nordisk's Tresiba (insulin degludec), in controlling blood sugar.
"Delays in initiating treatment and the burden of daily injections can have a real impact on patients' day-to-day experience managing type 2 diabetes," said Kenneth Custer, president of Lilly's cardiometabolic health unit.
"Onswik offers a new once-weekly basal insulin option for patients and reflects our continued commitment to deliver innovative treatment options that expand choice and provide greater flexibility in how people manage type 2 diabetes."
Novo could still have a little time to establish Awiqli's presence in the US market before Onswik becomes available, as Lilly said that it will launch the new product "in the coming months."
Meanwhile, pricing for Lilly's product isn't available yet, while Novo set a list price of $99 per single-unit package for Awiqli, with insured patients paying as little as $35 per month and uninsured/self paying no more than $55 per month under its access programmes.
Biolinq claims a first with needle-free OTC sensor
Onswik's approval came just before the FDA cleared the first over-the-counter, needle-free autonomous wearable – Biolinq Shine – that is able to track glucose, physical activity, and sleep in a single device. OTC approval of Biolinq Shine comes after it was cleared in the US as a prescription-only product last year.
Biolinq's device is worn on the forearm and sports a built-in display that allows users to view real-time changes in glucose levels, along with activity and sleep data, without the need to link to a phone. The company said the device is intended for adults aged 22 and older who are not on insulin.
