Exubera recommended by European regulator
pharmafile | October 18, 2005 | News story | Sales and Marketing |Â Â Â
Exubera, the first ever inhaled insulin product is set for approval in Europe following a key regulatory recommendation.
The positive opinion from Europe's CHMP and a similar FDA recommendation in September puts the rapid-acting insulin product on track for launch in early 2006.
Long-standing concerns that the drug could damage the lungs of patients in the long-term have delayed the drug by around three years, with co-marketers Sanofi-Aventis and Pfizer conducting additional phase III work to demonstrate its safety.
Questions have also been raised about the drug's efficacy in different types of diabetes, but the EMEA and FDA are now satisfied the product will be safe and of benefit to many patients.
The companies are seeking a licence for adults with inadequately controlled type II diabetes to use Exubera in addition to their oral diabetes treatments. In patients with type I diabetes, the drug will be used in combination with a long, or intermediate, acting injectable insulin.
FDA experts have stressed Exubera will not be suitable for all diabetes patients, and that the change to an inhaled product will require a large-scale education programme.
In particular, the FDA committee which recommended its approval has requested long-term studies into the safety of the drug in patients with respiratory problems, including the effect of passive smoking.
Despite such concerns, Exubera is forecast to earn $500 million in sales in its first full year on the market, and is expected to reach peak sales in excess of $1 billion.
Pfizer and Sanofi-Aventis hope Exubera's formulation will help patients who are concerned about using injectable forms of insulin.
Exubera is a rapid-acting insulin inhaled into the lungs before meals. The product's proprietary inhalation device and powdered insulin formulation were developed by Nektar Therapeutics.
In Europe, approximately 22.5 million people suffer from diabetes, with type II diabetes accounting for 85-95% of cases.
Two rival inhaled insulin products are in phase III development, Lilly/Alkermes' product is due to be filed after 2007 and Novo Nordisk/Aradigm's NN1998 (AERx) could reach the market by 2009.
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