What You Missed From Regulatory Agencies Last Week—July 21-25, 2014

NICE Recommends Bristol-Myers Squibb’s Yervoy

The National Institute for Health and Care Excellence (NICE) backed Bristol-Myers Squibb’s Yervoy (ipilimumab) as a first line treatment in cases where the cancer has spread or tumor removal is impossible. The drug was already NHS approved as a second line treatment for advanced malignant melanoma. Now, with NICE’s ruling, the drug can be provided to patients before they receive chemotherapy. In order for this recommendation to be valid, BMS is required to provide the drug at a discount through a patient access scheme.  The drug, which earned $1B in 2013, is expected to go up against GSK’s Mekinist and Merck’s pembrolizumab.

NICE Gives Astellas Pharma Nod For Xtandi

Prostate cancer treatment Xtandi (enzalutamide) was backed by NICE for the treatment of patients who have been treated with docetaxel and for those whose cancer has metastasized. Astellas will be required to provide the drug through a patient access scheme. The drug encountered some difficulties on its path to recommendation, as a previous guidance heavily restricted the drug’s use. However, these restrictions have since been overturned.

EU Accepts Malaria Vaccine Candidate For Review

GSK’s malaria vaccine candidate, RTS,S, was accepted by the EMA for regulatory review. RTS,S is composed of Agenus’ QS-21 Stimulon adjuvant—part of GSK’s AS01 proprietary adjuvant system to enhance immune response in combination with antigens. Malaria is responsible for 600,000 deaths a year—especially children in Sub-Saharan Africa—and there is currently no vaccine available for malaria prevention. GSK put the candidate through a phase 3 program in 13 African research centers in eight African countries. A positive opinion for the vaccine could lead to a policy recommendation and potential marketing authorization applications.

Biogen Idec’s Plegridy Given Marketing Authorization In EU For RRMS

The EC has granted Biogen Idec marketing authorization for its Plegridy (peginterferon beta-1a) in relapsing-remitting multiple sclerosis (RRMS). The treatment is dosed every two weeks and is administered subcutaneously with the Plegridy pen autoinjector. The EC approval is based on results from the ADVANCE1 trial that was centered on more than 1,500 patients with RRMS. In the trial, dosing Plegridy every two weeks reduced annualized relapse rate (ARR) at one year by 36 percent vs. placebo. Efficacy continued through the second year of the ADVANCE trial. This is Biogen Idec’s fifth therapy for MS.

NICE Updates View On Blood Clot Drug From Eli Lilly

NICE has adjusted its guidance for Eli Lilly’s drug blood clot prevention drug Efient so that the drug can reach a wider patient pool. According to the revised guidance, the drug should now be taken with aspirin to prevent blood clots in people with a history of heart attack or who have unstable angina. Patients who also undergo a procedure to widen arteries in the heart are eligible for this treatment. In 2009, the guidance recommended that Efient be used in combination with aspirin to prevent atherothrombotic events in people with acute coronary syndromes who have percutaneous coronary intervention.

Amitiza Gains NICE Recommendation

Sucampo announced that its constipation treatment Amitiza received recommendation from NICE. The drug’s guidance specifies that the drug be used for treating chronic idiopathic constipation (CIC) for patients who have not been helped by at least two high-dose laxatives from different classes.

Janssen’s Imbruvica Earns Positive CHMP Opinion

Janssen’s Imbruvica received a positive opinion from the CHMP and is recommended for marketing authorization. The drug is indicated for the treatment of relapsed or refractory mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) for adult patients who have received one prior therapy. The drug can also be taken as a first-line treatment in cases where there is 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. The recommendation follows the phase 3 RESONATE and phase 1b (PCYC-1102) studies in CLL and the phase 2 (PCYC-1104) study in MCL.

EC Approves Bristol-Myers Squibb’s Eliquis for DVT

Bristol-Myers Squibb also announced that the EC has approved Eliquis for the treatment of DVT and PE and for the prevention of recurrent DVT and PE in adults.  The drug is currently also approved in the EU for prevention of venous thromboembolism (VTE) in adults undergoing elective hip or knee replacement surgery and for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). This approval follows two pivotal phase 3 trials, AMPLIFY and AMPLIFY-EXT.

Roche Leukemia Treatment Granted EC Approval

Gazyvaro (or Gazyva in the U.S.) for the treatment of patients with chronic lymphocytic leukemia and surgery-preventing comorbidities, received EC approval. The drug is to be taken in combination with chlorambucil chemotherapy.  Gazyvaro was investigated in the CLL11 study and was found to significantly reduce the risk of disease progression or death by 61 percent compared to MabThera/Rituxan plus chlorambucil.

CHMP Recommends Allergan’s Ozurdex

The EMA CHMP has given a positive recommendation for the extension of the marketing authorization for Ozurdex as a treatment for vision loss cause by diabetic macular edema (DME). The drug is specifically targeted toward those DME patients who are pseudophakic, or who have had no response to or are ineligible for non-corticosteroid therapy. The final decision for the marketing authorization is expected within a few months. The drug is already available throughout the EU to treat macular edema in patients with retinal vein occlusion (RVO) and for inflammation of the posterior segment of the eye.