China approves Novartis' multiple sclerosis drug Gilenya

Novartis announced Friday that China's National Medical Products Administration (NMPA) approved Gilenya (fingolimod) for relapsing forms of multiple sclerosis for adults, as well as for children aged 10 years and older. "The approval of Gilenya and the upcoming regulatory review for [multiple sclerosis drug] Mayzent (siponimod) demonstrate our commitment to Chinese patients," commented Marie-France Tschudin, president at Novartis Pharmaceuticals. 

The company noted that the authorisation marks "the next key Novartis product approved from the list of urgently needed drugs in China." Novartis received Chinese approval of Cosentyx (secukinumab) earlier this year for use in certain adults with moderate-to-severe plaque psoriasis, while the heart failure drug Entresto (sacubitril/valsartan) was cleared in the country in 2017.

Sales of Gilenya fell 5% in the second quarter to $825 million, primarily due to competitive pressure in the US. Meanwhile, Novartis filed lawsuits in the US last year against more than 20 companies seeking to block the entry of generic competition for Gilenya. Prior to that, the Patent Trial and Appeal Board of the US Patent and Trademark Office had upheld the validity of the dosage-regimen patent protecting the treatment.   

To read more Top Story articles, click here.