OR WAIT null SECS
New drug aims to turn obesity into treatable chronic condition.
One remarkable feature of Novo Nordisk’s Wegovy (semaglutide) story is the lightning speed of the US launch, one of the fastest ever for the organization. The sales team was in the field with the obesity drug just 72 hours after its FDA approval on June 4, 2021; it hit the pharmacy shelves on June 18. Doug Langa, executive vice president, head of North America operations and president, Novo Nordisk US, attributes this giddying momentum to a “one-team approach.” The drug had already sped quickly through the FDA approval process thanks to a priority review voucher; in the face of a condensed timeline, “everybody really stepped up,” Langa told Pharm Exec. “From development through regulatory to sales and marketing, we all worked together with a singular purpose.”
Even with the COVID pandemic pushing pharma to raise its game like never before, we might ask what the hurry was. But Novo has been eager to move forward with Wegovy since Phase III results released in February showed that one-third of patients taking semaglutide lost more than 20% of their body weight during the 68-week trial. Novo’s existing obesity treatment, Saxenda, launched in the US in 2015, was doing “solid business,” but this drug requires a daily injection; patients taking Wegovy need just a weekly injection. Further, Wegovy is “significantly more potent than all of the currently available weight loss medications,” Novo has stated. What’s more, the 100,000 patients taking Saxenda represent just “a small fraction of the patient pool,” Langa told Pharm Exec. “We have a hundred million people in the US with obesity, roughly 42% of the adult population. And less than 3% currently receive anti-obesity medications (AOMs), so there is a huge unmet need for a treatment like Wegovy to help people lose weight and keep it off.” It seems clear why Novo didn’t want to wait around.
Still, for Langa, a 30-year veteran of pharma, obesity remains “one of the most challenging disease states” he’s been involved in. “It’s still misunderstood; it’s still underdiagnosed. There’s still this stigma and bias associated with it,” he explains. “It’s gut-wrenching at times to hear people say obesity is not a disease, it’s just a result of lack of willpower. But we know that it’s a matter of biology. It is a serious chronic and progressive disease; it’s associated with decreased life expectancy and is a gateway into something like 60 other health conditions.” For years now, Novo has been focusing on three areas to improve understanding around obesity, and this work continues apace. The first is getting more healthcare professionals to recognize obesity, to treat it as a chronic disease, and be willing to write prescriptions for it, along with recommending diet and exercise. “Quite simply, we need more HCPs treating obesity,” says Langa. Second, he says, there aren’t enough people with obesity seeking treatment; the aforementioned stigma is preventing those with the disease from talking to HCPs about it. The third issue is the problem of payer resistance to putting AOMs on the formulary. “We need access and reimbursement, just like any other product,” says Langa. “Seniors, for example, can’t even get a prescription benefit in Part D for AOMs and obesity medication.”
The promotional campaign around Wegovy, offering virtual training sessions for 5,000 HCPs and the creation of an educational website called Rethink Obesity, looks however to have played a big part in combating the negative thinking around the disease. “Unaided awareness” of Wegovy among HCPs is over 50%, “which is really incredible for a launch product,” says Langa. More than that, when the drug hit the market, initial demand outstripped supply, resulting in product delays of up to four weeks. Novo is ramping up production of Wegovy in an attempt to close this gap. “We take ownership of this issue and we’re working 24/7 to correct it,” says Langa, “but it’s going to take some time to meet the demand.” He expects this to happen “by early 2022, if not sooner.”
Temporary shortage issues aside, the response to Wegovy’s launch led investment banking company Jefferies to report that the drug “has the potential to at least double or triple” the obesity market. Taking a more measured tone, Langa told Pharm Exec, “We’re certainly encouraged and enthused about the early interest from HCPs, but we need to work through the current supply constraints first and then see what the demand curve finally looks like.” The most important thing, he adds, is that “we believe in the clinical profile of the product and what it can mean for patients.”
Read the profiles of all 2021 product launch selections here.
Julian Upton is Pharm Exec’s European and Online Editor. He can be reached at firstname.lastname@example.org.