FDA has announced approval of Eli Lilly’s Emgality (galcanezumab-gnlm), the first treatment for episodic cluster headache that reduces the frequency of attacks. Decision was made based on a clinical trial that compared the drug to placebo in 106 patients, and found that during a three-week period, patients taking Emgality experienced 8.7 fewer weekly cluster headache
FDA has accepted Merck & Co’s anti-PD-1 therapy, Keytruda, in combination with Eli Lilly’s pemetrexed and platinum chemotherapy as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). The regulators has also granted Priority Review to this application. This supplemental application is based on overall survival and progression-free survival (PFS) data
Eli Lilly’s experimental breast cancer drug, abemaciclib, has been granted a priority review by US regulators for two indications, and is now on track to be filed in Europe later in 2017.
Patients with soft tissue sarcoma in England and Wales look set to gain routine NHS access to Eli Lilly’s Lartruvo after NICE backed funding for the drug in draft guidelines. Lartruvo in combination with doxorubicin has been recommended by the cost regulators as an option for advanced soft tissue sarcoma in adults who have not
Patients with plaque psoriasis will be able to gain routine access to Eli Lilly’s Taltz on the NHS within the next three months if they meet certain eligibility criteria. NICE, has published final guidelines backing use of the drug but only if the disease is severe, as defined by a total Psoriasis Area and Severity
Eli Lilly’s Olumiant has achieved its first regulatory approval with a nod from the European Commission to treat moderate-to-severe active rheumatoid arthritis. The decision allows the treatment to be used either as a monotherapy or in combination with methotrexate to treat adult patients with the condition who have responded inadequately or are intolerant to one
At a meeting last week, the Committee for Medicinal Products for Human Use (CHMP) backed non-new drugs for approval, which included two drugs from AstraZeneca.
Boehringer Ingelheim and Eli Lilly Diabetes Alliance have announced that regulators for the National Health Service in England have deemed their drug, Jardiance (empagliflozin), as value for money. The drug has been recommended by the National Institute for Health and Care Excellence (NICE) for treating some patients with type II diabetes. The endorsement is a
The European Commission has granted regulatory approval to Eli Lilly and Boehringer Ingelheim’s Abasria for treating diabetes in adults, adolescents and children aged two years and above. The approval follows EMA’s Committee for Medicinal Products for Human Use (CHMP) positive recommendation earlier this year. The previous recommendation noted that clinical studies of the insulin showed
The National Institute for Health and Care Excellence (NICE) have granted expanded regulatory approval for Eli Lilly/ Daiichi Sankyo’s bloodthinner Efient to help prevent atherothrombotic events. NICE published guidance endorsing Efient when given with aspirin, to avert blood clots in patients who either have had a heart attack, have unstable angina, or are undergoing percutaneous
