Three AstraZeneca drugs recommended by EMA committee
pharmafile | December 21, 2015 | News story | Sales and Marketing | AstraZeneca, Brilique, CHMP, EMA, Portrazza, Tagrisoo, lesinurad, lilly
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended several new drugs in its latest meeting, including three AstraZeneca drugs and a Lilly treatment for non-small cell lung cancer.
The committee adopted a positive opinion recommending the marketing authorisation of lesinurad, in combination with a xanthine oxidase inhibitor (XOI), for hyperuricaemia, a symptom of gout, in adults. The drug is already recommended for approval by an FDA committee in the US – despite concerns about the drug’s safety. AstraZeneca acquired the drug in a $1.3 billion buyout of Ardea Science in 2012.
The CHMP also recommended approving Tagrisso (osimertinib) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). Patients in the UK have been among the first in Europe to access the drug, before the EMA’s decision, through the MHRA’s Early Access to Medicines Scheme. It is already approved in the US.
Brilinta (ticagrelor) is a third AstraZeneca drug given the thumbs up by the EMA committee, who gave a positive opinion to expanding the licence for the 60mg dose of the drug for patients with a history of heart attack who are at high risk of having a further atherothrombotic event. The opinion states that treatment may be started as continuation therapy after an initial one-year treatment with dual anti-platelet therapy.
Lilliy’s Portrazza (necitumumab) received its first regulatory decision in Europe, a fast-tracked positive opinion from the CHMP, as a treatment for use in combination with gemcitabine and cisplatin chemotherapy in adults with locally advanced or metastatic EGFR expressing squamous NSCLC, who have not received chemotherapy before. It follows the drug’s approval by the FDA in November.
In Europe in 2012, 313,000 patients were newly diagnosed and 268,000 people died from the disease, accounting for one in five cancer deaths. Approximately 80-90% of all lung cancers are NSCLCs, which occur when cancer cells form in the tissues of the lung. EGFR is a protein involved in the growth and spread of cancer cells.
Richard Gaynor senior vice president of product development and medical affairs for Lilly Oncology, says: “Today’s news is an encouraging step forward in bringing EU patients a much-needed frontline treatment option for this devastating type of lung cancer, which has a current five-year survival rate of less than five percent in patients with metastatic disease. Very little progress has been made for these patients over the past 20 years and few treatment options are possible.”
Lilian Anekwe
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