Oral GLP-1 competitiveness depends on price and convenience

Rybelsus may be hindered by pricy and inconvenient high-dose regimen

100 times more dosage than once-weekly injection, hemoglobin reduction at 1.3%

Although an oral GLP-1 drug, Rybelsus has attracted heightened attention from its market since its recent approval by the U.S.

 

Food and Drug Administration (FDA), it faces some barriers to overcome like inconvenient high-dose regimen and expensive price.

 

Reportedly, once-daily Rybelsus’ effect of glucose control and weight loss is not as effective as once-weekly injection, despite the oral drug’s dosage is hundred times higher than the injection.

 

And also the drug’s price is expected to be higher than other existing oral drugs.

 

Well aware of the concerns, Novo Nordisk (“Novo”) official spoke at a recently held third quarter 2019 earnings presentation and explained that competitors of Rybelsus would not be an once-weekly injection, but other existing oral antidiabetic treatments and Novo’s own once-daily injection, Victoza.

 

Rybelsus is an oral version of Novo’s once-weekly GLP-1 injection, Ozempic, and 7mg and 14mg doses of Rybelsus were approved by FDA in last September for type 2 diabetic patients, who needs to control glucose level with drug as they cannot self-control it by diet or exercise.

 

The biggest risk factor of Rybelsus is in effectiveness.

 

Rybelsus’ glycated hemoglobin reduction rate, which measures treatment effect on diabetic patients, demonstrated similar level of effectiveness as Novo’s own once-daily injection, Victoza.

 

However, the rate was less promising than Novo’s other once-weekly antidiabetic injection Ozempic.

 

According to Novo’s clinical data, taking 14mg of Rybelsus daily for 52 weeks would reduce 1.3 percent of hemoglobin level, whereas 26 weeks of taking 1.8mg of Victoza daily reduces 1.3 percent, and 40 weeks of 1mg of Ozempic weekly reduces 1.8 percent.

 

Treatments in GLP-1 class take a certain period of time to find patient’s adequate dose to minimize the treatment’s well-known adverse reaction, gastrointestinal side effects.

 

For Rybelsus, it takes about eight weeks.

 

Other injectable Saxenda by Novo, Trulicity by Eli Lilly, and efpeglenatide by Sanofi take about four weeks or less.

 

Unlike the Korean market, market expectation on Rybelsus is also lowered by diabetic patients in the U.S.

 

and other European countries not minding so much of pen-type injection device.

 

Clinical trial on single-dose prefilled pen-type injection conducted by Eli Lilly found 99 percent of subject patients completed administration for the target period of four weeks, and 97 percent of them were positive about continuous use of the treatment type.

 

Moreover, Rybelsus’ 14mg high-dose daily regimen is another issue the treatment faces, because such high dosage could lead patient’s pharmaceutical expense to rise.

 

In fact, Rybelsus’ injectable version, Ozempic’s treatment dosage is 1mg per week, but patients taking Rybelsus has to take 98mg (14mg per day) a week of the exact same substance, which is close to a hundredfold of Ozempic.

 

The industry accordingly expects the extensively higher dosage of the drug would inevitably increase patient’s drug expense.

 

“Rybelsus is ‘just another option of oral antidiabetic treatments’ and it is expected to take its unique place in the market.

 

But it has some problems to overcome, compared to an existing once-weekly injection.

 

Rybelsus’ competitors would likely to be other options of oral antidiabetic treatments or once-daily injection like Victoza.

 

Whichever product demonstrates the most outstanding effect, benefit, convenience and safety among once-weekly injections would lead the market, eventually,” a pharmaceutical industry insider commented.