European approval of the three self-administration pen injectors follows regulatory nods in other markets, including Australia, Canada and New Zealand. Patients in Europe will now be able to benefit from what Merck Serono claims is a more convenient drug delivery method.
"Merck Serono is continuously working on improving its administration devices in order to meet patients' and healthcare professionals' needs", said Bharat Tewarie, senior vice president, global business unit fertility and metabolic endocrinology at Merck Serono, a division of Merck KGaA.
After administration the pens immediately confirm if a complete dose was delivered. If an incomplete dose was delivered the pen informs the user of the missing amount.
The approved products are Gonal-F (follitropin alfa), in three sizes, Luveris (lutropin alfa), and Ovitrelle (choriogonadotropin alfa). All three products are recombinant gonadotropins used in fertility treatments.
Fertility is one of five therapeutic areas at Merck Serono and this week the company awarded up to €1m ($1.4m) to five research projects in the field. Funding of each fertility research project is dependent on achieving predetermined milestones.
Introducing fertility treatments in a prefilled pen injector form follows the UK launch of Rebif (interferon beta-1a), a multiple sclerosis (MS) treatment, in a similar delivery device.
“We believe the quick three-step injection process with RebiDose is an attractive option for an MS patient who is having trouble adhering to their current injectable MS therapy", said Andrew Paterson, director of neurology at Merck Serono.
Using an alternative delivery method is also a tactic to help companies maintain sales despite competition from low-cost generics.