New regulatory submissions for AbbVie and Novo Nordisk
pharmafile | December 4, 2015 | News story | Medical Communications | AbbVie, EMA, FDA, Novo Nordisk, Viekira Pak, insulin aspart
AbbVie and Novo Nordisk have submitted new drug applications to the US FDA and European Medicines Agency (EMA) respectively.
The FDA accepted AbbVie’s application for a once-daily, fixed-dose formulation of the components of Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir tablets), while the EMA will make a decision on Novo Nordisk’s faster-acting insulin aspart. Novo added that it also expects to file an new drug application with the FDA by the end of 2015.
Viekira Pak is an all-oral treatment already approved in the US for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection. The proposed dosing for the new fixed-dose formulation is three oral tablets once daily with a meal. AbbVie says this potentially offers another treatment option for patients to the current twice-daily, three-tablets regimen that launched around a year ago.
An estimated 2.7 million people are chronically infected with HCV, and genotype 1 is the most prevalent form of the disease in the US, accounting for approximately 74% of cases. AbbVie said it expects a decision by the US regulator in the second half of 2016.
Insulin aspart
Meanwhile, Novo Nordisk has sought European marketing authorisation for faster-acting insulin aspart: a mealtime insulin for improved control of postprandial glucose excursions, which it has developed for type 1 and type 2 diabetes patients.
The filing of faster-acting insulin aspart is based on the results from the ‘onset’ clinical trial programme, which involved around 2,100 people with type 1 and 2 diabetes. In the onset programme, people treated with faster-acting insulin aspart achieved improvements in postprandial control versus NovoRapid and a blood sugar reduction on par with another of the company’s insulin aspart products, NovoRapid.
Novo Nordisk said it would make the new faster-acting insulin aspart available in the prefilled delivery device FlexTouch.
“With the regulatory filing of faster-acting insulin aspart, we take yet another step in helping people with diabetes improve their blood glucose control around meals,” says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “Onset 1 shows that faster-acting insulin aspart has the potential to offer improved postprandial glucose and either an additional reduction of HbA1c or added flexibility compared with NovoRapid.”
Joel Levy
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