Regulatory Index News: 03/04/2018

Welcome to your Regulatory Index News update today. Exciting developments with some positive phase 3 data, a label expansion and a possible deal in the making.

Pfizer reports positive phase 3 results for new ATTR drug

Pfizer’s tafamidis yielded positive phase 3 trial (ATTR-ACT) results in treating transthyretin cardiomyopathy, a form of transthyretin amyloidosis (ATTR) which currently has no approved treatment. ATTR is caused by a mutation in the TTR gene which leads to TTR proteins that are unable to fold and can cause symptoms such as neuropathy and cardiomyopathy. The trial tested an oral daily dose of 20 mg or 80 mg tafamidis against placebo in 441 patients with hereditary transthyretin cardiomyopathy or the wild-type form of the disease. Results showed that tafamidis statistically decreased all-cause mortality and the frequency of cardiovascular-related hospitalizations at the 30-month mark. Whilst this is a positive result for Pfizer, the release has caused stock prices to drop in other ATTR drug developers, Alnylam and Ionis. Please click here to read more from a FierceBiotech article.

FDA expands Novo Nordisk's Tresiba label

Novo Nordisk has just won the approval to expand their Tresiba label after a study (DEVOTE) showed that Tresiba reduced the risk of hypoglycemia by 40% in diabetes patients compared to its competitor, Sanofi’s Lantus. This comes as great news to those Type 2 diabetes patients who suffer from severe hypoglycemia where data now suggests they are four times more likely to die within 15 days and two and a half times more likely to die overall. This hypoglycemia update, also accompanied by Lantus-matching cardiovascular safety data, may now give Novo the differentiating edge in the crowded basal insulin market. If you would like to read further on this, please click here for an article from FiercePharma.

Takeda exploring plans to buy Shire

Takeda has publicly revealed its interest in Shire to add to its core therapeutic areas. Whilst the Japanese company has not yet approached Shire’s board, they have made it clear that they are exploring the option of an offer and that a deal would strengthen its oncology, gastrointestinal and neuroscience portfolio, as well as accelerate its standing in specialised medicine. As Takeda has now expressed interest in the British drugmaker, it must now submit a bid by the 25th April or leave the deal. On top of this, interest may spark competing bids from other Pharma companies such as Pfizer or AbbVie, which have increased deal making bandwidth thanks to the US tax reform. Please click here to read this story in more depth from a PharmaTimes article.



Max Lymbery

Date Published

03rd April 2018

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