Regulatory Index News: 29/12/2017

Welcome to your Regulatory Index News update for today. Please take a read here for all your industry news.

Boxed warning for combo asthma drugs no longer required by the FDA

The FDA have dropped the need for a boxed warning, which has been present since 2011, about asthma-related deaths on the labels of drugs which contain both long-acting beta agonists and inhaled corticosteroids. This comes after four large clinical safety trials which tested the combined drugs in a 26-week, randomized, active-controlled trial with 41,297 patients in total. The data showed that combining them did not cause significantly more serious side effects than inhaled steroids alone. The studies also examined efficacy and found that the combined drugs were superior to inhaled corticosteroids alone at reducing asthma exacerbations. This should give more confidence to prescribers and patients with these combination treatments and may help with the market erosion faced in this area. Please click here if you would like to read more from a BioPharmaDIVE article.

FDA awards breakthrough status to Pfizer and Merck’s avelumab combo

Merck and Pfizer have gained their second breakthrough status designation in the US for a combination treatment of avelumab (Bavencio) with Inlyta for treatment-naïve patients with advanced renal cell carcinoma (RCC). This designation comes down to a preliminary evaluation of clinical data from a JAVELIN Renal 100 Phase Ib study, finding the combination to be of potential to offer substantial benefit over existing therapies, and will allow an expedited development and review for the treatment by the FDA. The findings of these studies showed that combining the treatments induced a response in 58.2% of patients with advanced RCC which is a much-needed result as five-year survival rates of this disease are still low. If you would like to read more into this, please click here for an article from PharmaTimes.

AstraZeneca and Imperial College London team up to tackle respiratory diseases

The drug maker, AZ, and Imperial College London have recently announced their plans to work together on researching the scientific mechanisms and underlying drivers of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). The three-year investigation will be led by AZ’s Mark Birrell and ICL’s Teresa Buckley, and will focus on mechanisms related to inflammation, neuropharmacology and lung irritancy. This open platform of research across industry and academia has proven mutually beneficial in the past and is hoped to “turn great science into innovative medicines for patients with debilitating respiratory diseases”. Please click here to read further in a PharmaTimes article. 



Max Lymbery

Date Published

29th December 2017

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