Novartis' new chronic obstructive pulmonary disorder therapies Ultibro Breezhaler and Xoterna Breezhaler are a massive step closer to winning European approval after an endorsement by the EMA’s Committee for Medicinal Products for Human Use.
Ultibro Breezhaler, which is also known as QVA149, is the first once-daily fixed-dose combination of an LABA (indacaterol, Onbrez Breezhaler) and a LAMA (glycopyrronium, Seebri Breezhaler) to gain a positive CHMP opinion.
Regulators are considering its use as a maintenance bronchodilator to relieve symptoms of COPD.
Clinical data have shown that it significantly improved lung function and patient-reported outcomes - including shortness of breath and reduced use of reliever medication - compared to current COPD treatments, the drugmaker noted.
Elsewhere, a green light has also been issued for the approval of Boehringer Ingelheim's lung cancer treatment Giotrif (afatinib).
The drugmaker is seeking the OK for the treatment of EGFR TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer with activating EGFR mutation(s).
According to the CHMP, increased progression free survival was observed in patients receiving the drug compared to those taking chemotherapy alone.
Takeda's dipeptidyl peptidase 4 (DPP-4) inhibitor alogliptin was also recommended, both as a standalone agent and in combination with other drugs for diabetes type II.
Clinical evidence for Incresync (alogliptin/pioglitazone), Vipdomet (alogliptin/metformin) and Vipidia (alogliptin) convinced the CHMP of the drugs' of blood glucose lowering capabilities, it said.
The Committee also backed Gilead's Tybost (cobicistat) for the treatment of human immunodeficiency virus-1 (HIV-1) infection in combination with protease inhibitors atazanavir and darunavir and Apotex' Grastofil (filgrastim), a biosimilar medicine for the treatment of neutropenia.
On the downside, Otsuka will be disappointed with the CHMP's decision to reject delamanid for the treatment of multidrug-resistant tuberculosis, on the basis that its benefits had not been shown by the evidence provided.
The group was concerned that the two-month study included in the submission was too short to establish the effectiveness of delamanid in treating TB when added to other anti-tuberculosis medicines, particularly as the drug is supposed to be used for at least six months.