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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