EMA, CHMP, NICE News Roundup: AstraZeneca, Gilead, Novartis, And More
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
AstraZeneca Drugs Gain Favor Of EU Regulators
AstraZeneca received several articles of good news from European regulators recently. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for Moventig (naloxegol) for patients with opioid-induced constipation (OIC) who have not been successfully treated with laxatives. The drug, an investigational, peripherally-acting mu-opioid receptor antagonist (PAMORA), was presented with results from the KODIAC clinical program that demonstrated the drug’s safety and efficacy. The application and CHMP opinion is now up for review by the European Commission (EC), which, should it approve Moventig, would make the drug the first once-daily oral PAMORA for OIC in EU member countries plus Iceland and Norway.
The company also announced it had received the go-ahead to expand the use of Iressa, a lung cancer drug. Now, patients are allowed to receive the drug after taking a blood test, whereas originally they needed to provide a tumor sample.
This came just several days after AstraZeneca got the good news that one of the respiratory drugs it had purchased from Almirall, LAMA/LABA—a combination of Almirall’s Eklira (aclidinium) and formoterol — was also recommended for approval by the CHMP.
Gilead Gets Positive CHMP Opinion For Harvoni
Hepatitis C treatment Harvoni gained a nod of approval from the CHMP last week following an accelerated review. The Marketing Authorization Application(MAA) for the drug, which is a combination tablet of NS5A inhibitor ledipasvir (LDV) 90 mg and sofosbuvir (SOF) 400 mg, will now be passed to the EC for the final decision. The drug showed efficacy in three Phase 3 studies, known as ION-1, ION-2, and ION-3, which enrolled 2,000 genotype 1 HCV patients with compensated liver disease. Several other trials demonstrated the drugs effect in patients with decompensated cirrhosis and pre/post-transplant patients (SOLAR-1) and those with genotype 3 and genotype 4 (ELECTRON-2).
Nintedanib Earns CHMP Recommendation For Approval
Boehringer Ingelheim announced that the CHMP has recommended approval of the drug nintedanib for patients to take in combination with docetaxel for adenocarcinoma (NSCLC) after first-line chemotherapy. The drug proved its worth in the LUME-Lung 1 clinical trial that showed the drug plus docetaxel was more effective in prolonging survival than docetaxel alone. If approved by the EC, the drug would enter the Boehringer portfolio with the company’s other previously approved oncology compound, known as afatinib — currently available in the U.S. as Gilotrif for several types of EGFR mutation-positive NSCLC.
CHMP Pushes Novartis Signifor To EC For Final Decision
Novartis’ Signifor, intended for patients with acromegaly, garnered a positive opinion from the CHMP last week, and, if approved, could be the answer for patients who need another treatment option to gain control of their disease. The disease, while rare, affects 10,000 in the EU, and is the result of increased levels of GH and IGF-1. Signifor was investigated in two multicenter Phase 3 trials, C2402 and C2305, during both of which, it proved its ability to maintain control of GH and IGF-1 levels compared to current standards of treatment.
Janssen Rezolsta, Prezista Looked Upon Favorably By CHMP
Rezolsta for HIV was given a nod of approval from the CHMP earlier this week to be taken in combination with other HIV antiretroviral medicines. Rezolsta is a combination of cobicistat (Gilead’s Tybost) and darunavir, which would eliminate the need for patients to take a boosting agent with each daily darunavir tablet.
Janssen also announced that darunavir (known as Prezista), also received approval for two label extensions. The drug can now be prescribed to children under 12, while the second extension allows cobicistat to be given as an alternative booster for darunavir in adults 18 years and up in combination with other antiretrovirals.
Nivolumab MAA Lands On EMA’s Desk For Review
The EMA accepted for review Bristol-Myers Squibb’s MAA for the company’s NSCLC drug, nivolumab (Opdivo). This marks the first time a PD-1 checkpoint inhibitor for NSCLC has been submitted for review by a regulatory agency. Opdivo went through a Phase 2 study in third-line pre-treated squamous cell NSCLC patients, the results of which encouraged the company’s regulatory submission to the EMA, as well as a rolling submission to the FDA. The drug was previously fast-tracked for melanoma and renal cell carcinoma, and it was named a Breakthrough Therapy by the FDA for Hodgkin lymphoma for those insufficiently treated with other standards of care.
Lundbeck’s Selincro Backed By NICE
The National Institute for Health and Care Excellence (NICE) just released guidance permitting the use of Lundbeck’s Selincro (nalmefene) in England for alcoholics also receiving counseling. The drug, which is currently available in Norway, Finland, Latvia, and other Northern European countries, is now available to help the estimated 600,000 patients in England cut down on the amount of alcohol they consume. The drug effects patients’ opioid receptors, which results in a decreased desire to drink, though it is not intended to help patients achieve total abstinence. When examined in trials, investigators found taking Selincro led to a 61 percent decrease in alcohol consumption, PMLive reports.