Novartis piling up approvals
regulators, potentially adding a few more products to its
'approved' list for this year.
The Swiss pharma firm has received EU approval of the first transdermal patch treatment for Alzheimer's, as well as two positive opinions from the Committee for Medicinal Products for Human Use (CHMP) for its combination Type II diabetes treatment and a Glivec (imatinib mesylate) alternative. Exelon (rivastigmine), Novartis' once-daily patch treatment for Alzheimer's patients, is the first and only transdermal patch therapy approved in the EU for patients suffering from mild to moderately sever Alzheimer's disease. Approval has come just two months after the company received a positive recommendation for the treatment from the CHMP, and follows the US approval granted back in July. The Exelon patch is the first application of the company's skin patch technology, and has been shown to achieve similar levels of efficacy to the highest doses of Exelon capsules whist reducing the incidence of gastrointestinal side-effects common with the oral Exelon form three-fold. The patch itself can be applied to the back, chest or upper arm to deliver steady levels of medication over 24 hours, whilst providing visual confirmation that the patient has taken their medication, says Novartis. The company will be hoping that approval will also follow on the heels of the positive recommendations it has received for two of its other treatments over the last few days. Following the positive CHMP opinion for Novartis' new oral diabetes treatment Galvus (vildagliptin) back in July, the company has now received a second thumbs up from the committee for a single tablet combination of Galvus and metformin for the treatment of Type II diabetes. Should the combo tablet, Eucreas, be approved, it will be the first single-tablet combination of a DPP-4 inhibitor and metformin available in the EU. Eucreas has been recommended for use in Type II diabetes patients for whom metformin treatment alone is inadequate, or for those currently taking Galvus and metformin separately. The combination pill is to be taken twice daily, either at a 50mg Galvus/850mg metformin dose or a 50mg Galvus/1000mg metformin dose. The new combined treatment brings together one of the most common oral diabetes medicines, metformin, with one of the new class of DPP-4 inhibitor drugs. The two agents together control patients' blood sugar levels by increasing insulin, decreasing glucagon and targeting insulin resistance. Galvus targets the dysfunction in the pancreatic islet cells that cause high blood sugar levels in patients with Type II diabetes, and metformin contributes by decreasing the production of sugar by the liver and increasing insulin sensitivity. In the CHMP's original opinion on Galvus, the committee recommended that the drug be used in combination with sulfonylurea as well as metformin, the broadest proposed indication for any member of the DPP-4 inhibitor class of drugs, according to Novartis. The third feather to Novartis' cap came as the CHMP also recommended Tasigna (nilotinib), the company's alternative to its multi-billion dollar drug, Glivec (imatinib). The treatment has been recommended for use in patients suffering from a rare form or leukaemia, who are resistant or intolerant to Glivec. The drug was created just one year after the launch of Glivec, and was first approved in Switzerland in July with a decision from US regulators expected by the end of the year.