Regulatory Index News: 02/03/2018

Welcome to your Regulatory Index News update today. Take a read to keep up to date with the added competition in breast cancer, a new EU approval and an accelerated assessment.

Lilly’s Verzenio wins expanded US approval

Eli Lilly’s breast cancer drug, Verzenio, won an expanded US approval as a first-line treatment with an aromatase inhibitor for postmenopausal women with HR+/HER2- metastatic breast cancer. This leaves Verzenio on a level playing field with Novatris’ Kisqali and Pfizer’s market dominating Ibrance. This presents a very challenging road ahead for Lilly’s Verzenio where it will need to turn to competitive advantages to gain a market share. All three of the drugs deliver at least a 40% reduction in the risk of disease progression, however Lilly can dose Verzenio on a continuous basis and has exhibited lower rates of neutropenia compared with the others. On the flip-side it does however show increased rates of diarrhoea, which Lilly believe will be manageable with concurrent use of loperamide. Please click here to read more on this story from a BioPharmaDIVE article.

EU approval for Roche/Chugai’s haemophilia treatment

The European Commission have licensed Roche/Chugai’s hemophilia A therapy, Hemlibra, for routine prevention of bleeding in patients with factor VIII inhibitors. Almost one third of patients with severe hemophilia A develop inhibitors or resistance to factor VIII replacement therapy, which reduces its efficacy and makes treating bleeding episodes more difficult with the current standard treatment. Hemlibra however is a bispecific monoclonal antibody which triggers the patient’s natural coagulation cascade leading to the restoration of the blood clotting ability. The phase 3 trial (HAVEN) showed that once-weekly Hemlibra reduced the number of treated bleeds by 87% after 24 weeks compared to ‘on-demand’ use of bypassing agents (BPAs), the standard of care. If you would like to read more, please click here for an article from PharmaTimes.

Accelerated EU assessment for Shire’s lanadelumab

An accelerated EU assessment pathway has been established for Shire’s lanadelumab, their hereditary angioedema (HAE) treatment for patients aged 12 and older. HAE is a rare genetic disorder (affecting 1 in 10,000-50,000) that leads to debilitating and painful swelling in the body which can be life-threatening. Lanadelumab treats this as a fully human monoclonal antibody which binds and inhibits kallikrein, presenting a different treatment approach. The drug has reported promising data from a pivotal phase 3 trial (HELP) which showed biweekly administration of lanadelumab resulted in an 87% reduction of HAE mean attack frequency. The study also showed no treatment-related serious adverse events or deaths. Lanadelumab has also gained US priority review. Please click here for further information from a PharmaTimes article.



Max Lymbery

Date Published

02nd March 2018

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