EMA, NICE, EC News Roundup: Roche, Boehringer Ingelheim, AstraZeneca, And More
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
Scotland Says No To Kadcyla
Kadcyla has once again been rejected for inclusion on the NHS in another country on the grounds of its price. This time, the Scottish Medicines Consortium has shaken its head over concerns about its cost effectiveness, while those in favor of the drug believe it to be an important method to extend life for women with inoperable breast cancer. This rejection follows NICE’s ruling that the drug was too expensive to be used on the NHS. Women who wish to be treated with the drug will need to attain it through the Peer Approved Clinical System (PACS).
AstraZeneca Gains Nod For Olaparib
AstraZeneca’s olaparib (Lynparza) for ovarian cancer was recommended for approval by the EMA’s CHMP this week—welcome news for the British Pharma giant considering the U.S. FDA panel in June voted against accelerating the experimental drug’s approval. Olaparib is designed to repair cells damaged by cancer in patients with certain hereditary gene mutations. Should it be approved by the EC, it would hold the record of being the first drug in the PARP inhibitor class to hit the European market. A final decision is expected in early January, 2015. An approval could garner upwards of $2 billion a year for AstraZeneca, Reuters reports.
2 Boehringer Ingelheim Meds Receive SMC Approval
Two drugs received a nod of approval to be used on the NHS from the Scottish Medicines Consortium: Dabigatran Etexilate (Pradaxa) for deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults; and Empagliflozin (Jardiance) as an add-on combination treatment in certain adults with type 2 diabetes.
NICE Votes Against Dendreon’s Provenge For NHS
Sipuleucel-T, an immunotherapy known by the brand name Provenge, was deemed too expensive by the National Institute for Health and Care Excellence (NICE) to be available to patients on the NHS in England. The non-cytotoxic drug was indicated for those with metastatic prostate cancer who had not yet received chemotherapy — a total of 4,600 people in England, the Pharma Times reports. According to NICE, while the drug elicited improvements in patients with the disease compared to those taking placebo, there were doubts that the drug performed better than existing treatments. Provenge also didn’t demonstrate an ability to keep the disease from progressing, unlike current treatments, including Johnson and Johnson’s Zytiga (abiraterone).
Imbruvica Approved By EC For Blood Cancers
Patients suffering from two blood cancers — refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) — now have a new treatment option in the EU, as the European Commission (EC) has approved Pharmacyclics’ and Janssen’s Imbruvica (ibrutinib). The treatment is indicated for those who cannot have chemotherapy, those who possess a 17p deletion or TP53 mutation, or those who have received at least one prior therapy. Imbruvica was investigated in the Phase 2 PCYC-1104 study and the Phase 3 RESONATE study in patients with CLL and small lymphocytic lymphoma (SLL) and in a Phase 1b/2 PCYC-1102 study in CLL/SLL. The drug is responsible for inhibiting the Bruton’s tyrosine kinase (BTK), which helps play a role in malignant B-cell survival and metastasis.
Immunomedics Granted Orphan Drug Designation
Isactuzumab govitecan (IMMU-132), a solid-tumor antibody-drug conjugate (ADC), was granted orphan drug designation for pancreatic cancer. The ADC is currently undergoing Phase 2 trials. Isactuzumab comprises a humanized antibody, hRS7, bound to the epithelial glycoprotein-1 antigen (EGP-1), known as trophoblast cell-surface antigen (TROP-2). After binding to TROP-2 — found in breast, cervix, kidney, liver, and prostate cancer— hRS7 enters cancer cells, making it an appropriate candidate to deliver cytotoxic drugs. When attached to isactuzumab govitecan, SN-38, the active metabolite of irinotecan, has demonstrated its efficacy at lengthening survival times and fighting tumors in animal models.
Clanotech Awarded Orphan Drug Designation
Clanotech’s α5β1-integrin antagonist indicated to heal wounds following glaucoma surgery received orphan drug designation last week. The drug works by inhibiting the α5β1-integrin receptor found in fibroblast and on vascular endothelial cells, in turn cutting down on the angiogenic, fibrotic, and inflammatory properties that follow glaucoma surgery.
GW Pharma Cannabidiol Granted EMA Orphan Designation
Epidiolex for Dravet syndrome (childhood epilepsy syndrome) now has an EMA orphan drug designation under its belt, along with Fast Track designation from the U.S. FDA, as well as orphan designations in Dravet and Lennox-Gastaut syndrome (LGS). In the next few weeks, the company plans to launch the first Phase 2/3 clinical trial investigating Epidiolex’s ability to treat both Dravet Syndrome and LGS.
NICE Recommends GSK Tafinlar For NHS
GSK’s skin cancer drug Tafinlar was recommended for inclusion on the NHS for BRAF V600 mutation patients with spreading or inoperable skin cancer. The drug will now be able to go head-to- head with its prime competitors in England and Wales: Roche’s Zelboraf (vemurafenib) and Astellas/Bristol-Myers Squibb’s Yervoy (ipilimumab), PM Live reports. NICE has also reported that Tafinlar is comparable to Zelboraf in tackling BRAF V600 mutations.
Ferring Pharma To launch New UC Treatment
Ferring Pharma’s Cortiment (budesonide) intended to cause remission of mild to moderate ulcerative colitis was granted marketing approval in the 27 EU member states. Since 2013, the drug has been available in the Netherlands, however in the upcoming months, the company expects the drug to become available in all 27 of the EU member states. The drug contains budesonide, a locally acting glucocorticosteroid, and is taken in tablet form once daily for as long as 8 weeks. When compared to placebo in Phase 3 studies, the drug brought about clinical and endoscopic remission of ulcerative colitis and is intended for those patients who do not respond well to aminosalicylate treatment.