Exactly when Europeans will first be able to access Wegovy in tablet form remains uncertain.
Following a positive recommendation from the EMA, it typically takes a couple of months before a company can launch a drug, explains Søren Løntoft Hansen. This points to a potential first European launch in the second half of the year, in line with Novo Nordisk’s guidance from May.
Løntoft Hansen also expects that Europeans will be able to access the tablet relatively soon after approval. However, even once the Wegovy tablet has been approved, Novo Nordisk must still negotiate with each individual member state regarding pricing and reimbursement terms, among other issues. It is precisely these individual negotiations that complicate the prospect of a simultaneous launch across Europe.
“Sometimes these negotiations go a little more smoothly and a little faster in some markets than in others. You almost never see a drug launch in Europe happening simultaneously across member states, and I don’t think that will happen in this case either,” he says.
Injection versus tablet
The length of time that Wegovy in injectable form has been available in various markets also plays a role, according to Søren Løntoft Hansen. The same applies to the approval of the high-dose Wegovy injection.
“Priorities must be set based on how one intends to position the product in each market,” he says, continuing:
“It may be that Wegovy in injection form has not been on the market for long, and that the company wants to expand its injectable presence before launching the pill version.”
Back in February, Novo Nordisk received approval for high-dose Wegovy in injectable form in Europe. The approval opened the door to treatment with a 7.2 mg dose instead of the previous 2.4 mg dose. However, this must be administered as three separate injections.
Last Friday, the EMA recommended approval of a single-dose 7.2 mg Wegovy injection. The company said in a press release that the high-dose version is expected to launch in the EU in the third quarter of this year.
Tight-lipped on capacity
As a final point relevant to the launch of the Wegovy tablet in Europe, Søren Løntoft Hansen notes that capacity could also be a factor.
Wegovy in tablet form contains more active ingredient than Wegovy in injectable form. This raises some capacity considerations to ensure Novo Nordisk does not end up in a situation with capacity constraints, he explains.
Novo Nordisk does not wish to comment on this.
Do you think Novo Nordisk’s production capacity is limiting the company’s launch ambitions for the tablet?
“Not necessarily in Europe, because you have to negotiate with each individual member state, so there will be a phased launch that will take some time in Europe,” says Løntoft Hansen, adding:
“I wouldn’t rule out a single large-scale rollout in Europe, but I don’t think it will happen. However, it is my impression that Novo does not have the capacity to launch the pill globally all at once.”