EU approval for Libtayo and Dovato; Boehringer expands NASH pipeline

EU approves the use of Libtayo for cutaneous squamous cell carcinoma

The National Institute for Health and Care Excellence (NICE), in a move to make cancer drugs available to common man, has issued guidelines regarding the funding of Libtayo (cemiplima). Libtayo, co-developed by Sanofi and Regeneron, was granted its first conditional marketing authorization in Europe for advanced cutaneous squamous cell carcinoma (cSCC) patients, who are unable to receive surgery or radiation therapy. It is a fully human monoclonal antibody, which targets the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the only treatment approved in advanced CSCC therapy market in the European Union (EU). The Cutaneous squamous cell carcinoma therapeutic market, presently, is driven by supportive (off-label) therapies due to the lack of approved targeted treatment of cSCC. DelveInsight estimates that availability of only approved therapy Libtayo, increasing incidence awareness of the disease and promising emerging pipeline therapies will strive forward the cutaneous squamous cell carcinoma market size during the forecast period of 2019-2028.

Boehringer expands its NASH pipeline, buys Yuhan’s liver disease drug

Boehringer Ingelheim has announced a strategic partnership with South Korea-based Yuhan Corporation to advance the Nonalcoholic Steatohepatitis (NASH) pipeline. Boehringer signed a collaboration and licensing agreement with Yuhan to advance treatment market of FGF21 biology, obesity and NASH. This time, Boehringer is eyeing a dual agonist against GLP-1—a target of various Type 2 diabetes drugs—and the liver hormone FGF21, paying Yuhan USD 40 million upfront and rest to USD 830 million in milestone payments on further sales. NASH is one of the main reasons why many Americans are undergoing liver transplantation at present. At present, NASH therapy market is mainly dominated by off-label therapies. The NASH market share of off label therapies will keep on experiencing steady growth until a standard approved therapy enters the NASH treatment market. However, companies like Genfit, Elafibranor, and InterceptPharmaceuticals are running clinical trials of their lead drugs to advance in NASH market.

ViiV Healthcare receive EU Marketing Authorisation for Dovato

ViiV Healthcare, the global specialist HIV Company, majority owned by GlaxoSmithKlilne, with Pfizer and Shionogi Limited as shareholders, for Dovato (dolutegravir/lamivudine). The drug is approved for the treatment of HIV-1 infection. So far, in the EU, HIV treatment comprised of the three-drug regimen. Earlier in the year, Dovato was approved for the HIV treatment by the US FDA. After the approval of Dovato, people struggling with HIV, for the very first time, will be able to start treatment on a once-daily, single-pill, two-drug regimen, being assured about the efficacy of the treatment.