In a first, Lilly's ready-to-use rescue hypoglycemia powder wins US approval
Days after Lilly’s chief of biomedicines Christi Shaw bid farewell to head up Novartis’ $NVS Kite business, the US drugmaker unveiled a fresh approval: a severe hypoglycemia treatment — the first such therapy given the nod in the United States that can be administered without an injection.
Severe hypoglycemia — rapidly falling blood sugar levels that lead to symptoms such as confusion or syncope — typically occurs in diabetics using insulin treatment.
Until now, if a patient had a hypoglycemic episode, they would have to be treated with a glucagon injection — first approved decades ago — that first would have to be mixed in a several-step process. Lilly’s $LLY Baqsimi, which is a powder administered into the nose, is convenient: compact, portable and ready to use in patients aged four and beyond.
Acquired by Lilly from Locemia Solutions in 2015, Baqsimi enhances blood sugar levels by stimulating the liver to release stored glucose into the bloodstream. In two trials — one with 80 patients and the other with 83 patients — Baqsimi was found to be equally effective as injectable glucagon.
Baqsimi is expected to be stocked in retail pharmacies within one month, and the product carries a US list price of $280.80 for one-pack and $561.60 for a two-pack, Lilly said, noting that it is discussions with insurance providers to secure reimbursement. “Eligible commercially insured people with diabetes can pay as little as $25 for up to two Baqsimi devices (1 two-pack or 2 one-packs) if they use the savings card,” the company added.
The US drugmaker — one of the trio of big global insulin makers: Sanofi $SNY and Novo Nordisk $NVO that serves the United States — has been in the spotlight as scrutiny into insulin pricing in the United States intensifies. The region is home to about 1.25 million type 1 diabetics, according to the American Diabetes Association (ADA), which estimates the average price of insulin has nearly tripled between 2002 and 2013. Reports of diabetics rationing and forgoing insulin have become commonplace.
In March, Lilly issued a report breaking down what it gets paid, on average, versus the list price of its insulin treatments. Between 2014 and 2018, the list price for Humalog — Lilly’s most popular insulin — increased 51.9% while the average amount that Lilly received — the net price — declined by 8.1%, as the company increases (and in some cases is forced to hike) the magnitude of rebates and discounts it offers. That month, the drugmaker also pledged to launch a half-price generic of Humalog, which generated nearly $3 billion in 2018 sales.
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