Welcome to your Regulatory Index News update today. A novel US approval, a stimulating negotiation and label expansion makes for an interesting read.
US approval for first-ever inherited rickets therapy
The FDA have approved Ultragenyx and Kyowa’s Crysvita, a treatment for x-linked hypophosphatemia (XLH) in both adults and children. The disease is an inherited form of rickets which causes low levels of phosphorous in the blood which leads to impaired bone growth and development as well as bone mineralisation problems throughout the patient’s lifetime. The treatment is an antibody that blocks the fibroblast growth factor 23 (FGF23) leading to decreased phosphate urinary excretions and increased active vitamin D production. Its dosing regimen is also believed far less burdensome than other current therapies. If you would like to read more, please click here for a PharmaTimes article.
After three rejected proposals, Takeda makes heavier $63B bid for Shire
Shire have confirmed that it has rejected three merger proposals from Takeda with the last being valued at approximately $44 billion. Takeda have however now returned with a bigger offer of £47 per share, from the previous $46.50, making it £21 in cash (dollars) and £26 in shares. Shire have responded that they will be considering its position and will issue further announcement in “due course”. Allergan were also involved in the bid for Shire but it was not to last after a 7% share price fall in just 4 hours. Now only time will tell whether Shire will agree to negotiating a deal or whether another company joins the bidding war. Please click here for more in an article from Endpoints.
AstraZeneca’s Tagrisso gains a US label expansion in lung cancer
The US administrators have cleared AZ’ Tagrisso to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations as a first-line treatment. Whilst the drug was already approved for second-line use, data from a phase 3 trial (FLAURA) showed that Tagrisso increased progression-free survival (PFS) to18.9 months compared to10.2 months with the current EGFR-TKI first-line therapies, erlotinib or gefitinib. The treatment is also under review in the EU and Japan to treat patients in the first-line setting. Please click here to read further from a PharmaTimes article.