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Sanofi’s Lantus successor Toujeo launched in the US
Toujeo (glargine U300) is available only in a 1.5 mL disposable device (450 U/1.5mL), a modified
SoloStar pen. The US label does not include clinical relevant benefits compared to Lantus, such as
better HbA1c reduction or lower rate of hypoglycaemia, and it further highlights that higher doses of
Toujeo are needed to maintain the same glycaemic control. Sanofi has a declared ambition of driving a
substantial Lantus to Toujeo conversion within the next years. Toujeo received positive opinion in the
EU on 27 February 2015, and approval is expected end of April.
Comment: The lack of label advantage over Lantus makes it more challenging to execute the switch
from Lantus to Toujeo and to argue for a differentiation to upcoming biosimilar glargine products. Still,
the large installed base of Lantus patients will enable Sanofi to retain a significant share of the basal
insulin market in the US with Toujeo and Lantus.
Modest initial uptake of Sanofi & MannKind’s pulmonary human insulin Afrezza in
the US
Afrezza was launched late January in the US. Sanofi is positioning Afrezza for T2DM patients suboptimally
treated due to reluctance to initiate injections or intensify insulin therapy with injectable rapidacting
insulin. Compared to rapid-acting insulin analogues, Afrezza is priced at 80-160% premium per
unit. Initial market uptake has been quite modest with only 160 prescriptions (TRx) in the sixth week
of launch.
Comment: Despite the lack of injection and a small inhaler, Afrezza is hampered by a lower efficacy
than NovoRapid®/NovoLog® and a high price. Hence, Afrezza is expected to be a niche product as also
witnessed by the low number of prescriptions.
New basal insulin peglispro delayeduntil at least 2018 due to safety concerns
Eli Lilly has delayed regulatory submission until after 2016 in order to generate additional clinical data
to further characterise side effects observed in phase 3 trials. Top-line results from phase 3 showed a
strong efficacy profile for peglispro including superior HbA1c control vs Lantus; however, side-effects
including increases in LDL cholesterol, liver enzymes and liver fat were also reported.
Comment: Peglispro will not enter the US market until at least 3 years after Sanofi’s Toujeo and 2½
years after Novo Nordisk’s Tresiba®. However, this may lead to a more aggressive strategy for Eli
Lilly+Boehringer Ingelheim’s biosimilar glargine Basaglar expected to launch mid 2015 and mid 2016
in Europe and US, respectively.
Eli Lilly launches once-weekly GLP-1 Trulicity in
Europe and broadens US launch to primary care
Trulicity (dulaglutide) has initially been introduced in UK and Germany,
and more European markets will follow during 2015. Trulicity was
launched November 2014 in the US, initially targeting endocrinologists.
During February, the launch has been broadened to also target
primary care physicians. Still, uptake in the US has been modest and
Trulicity only has about 4% volume market share of the GLP-1
market as of mid April.
Comment: Trulicity offers once-weekly dosing and has shown noninferiority
vs Victoza® on glycaemic control, but with less weight loss.
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