ProStrakan’s cancer pain product, Tibotec’s HIV treatment, and a label-extension for Cymbalta were all recommended for approval.
The European regulatory advisory committee is backing the approval of ProStrakan’s cancer pain drug, Tibotec’s HIV therapy, and a medication for generalized anxiety disorder (GAD) from Eli Lilly and Boehringer Ingelheim.
ProStrakan in-licensed exclusive European rights to the cancer pain treatment Abstral from Orexo. Abstral is a fast-dissolving tablet for sublingual administration of fentanyl intended for patients who are already receiving opioid analgesics.
The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) allows ProStrakan to obtain national licenses throughout the EU. Following receipt, ProStrakan expects to launch Abstral across Europe by the end of this year. ProStrakan has agreed, as a postapproval commitment, to supply the EMEA with final study reports and relevant analyses, when available, from the ongoing clinical program in North America. The company says that it will start marketing the product in Sweden, where it is already sanctioned, in the third quarter.
Tibotec, on the other hand, expects to receive a conditional marketing authorization for its HIV medication, Intelence™, from the European Commission in the coming months. If approved, it could be the first new nonnucleoside reverse transcriptase inhibitor (NNRTI) to be introduced in approximately 10 years, according to Tibotec. Intelence will be indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced adult patients.
The treatment It is the first to show efficacy in patients with NNRTI-resistant virus, Tibotec reports. The proposed indication for Intelence requires that it is used in combination with a boosted protease inhibitor and other antiretroviral products.
If the European Commission abides by CHMP’s recommendation for Eli Lilly and Boehringer Ingelheim’s drug, it would mean a label-extension for Cymbalta. The product is already approved for the treatment of depression, diabetic peripheral neuropathic pain, and stress urinary incontinence in various countries. The drug gained marketing authorization for the treatment of GAD in Mexico in 2006 and in the U.S. last year.