Sanofi-Aventis and Pfizer have been boosted on news that their inhaled insulin, Exubera (human insulin powder), is both effective and well tolerated in patients with type 2 diabetes.
According to three two-year studies presented at this week’s American Diabetes Association meeting, Exubera provided effective, sustained glycaemic control and was well tolerated over two years in adults with type 2 diabetes. The most common side effects reported in the trials were hypoglycaemia and cough.
Exubera – a dry powder form of insulin that is inhaled into the lungs prior to eating – is being developed for patients with type 1 and type 2 diabetes, but has been dogged by concerns over lung function decline. The two firms had originally hoped to file for the regulatory green light as early as 2001, but were forced to delay their plans and conduct additional clinical trials [[03/05/02b]]. The drug was redeemed when data suggested that the lung function decline, which had been seen at six months, leveled out after one year [[15/10/02e]], and it has since been filed with both the US and European regulatory agencies [[04/03/04a]], [[03/03/05c]].
- Meanwhile, Alkermes’ share price rose a not insignificant 6% on the Nasdaq Stock Exchange yesterday after partner, Eli Lilly, said their experimental inhaled insulin product was as effective as injectible insulin in treating patients with type 1 diabetes.
The companies plan to begin enrolling patients with type 1 and type 2 diabetes who also have chronic obstructive pulmonary disease or asthma, as well as patients with type 1 diabetes without lung disease, into additional clinical studies next month.