Merck KGaA has been boosted by the news that regulators in Australia have approved cladribine, its oral treatment for multiple sclerosis.
The German drugmaker's Merck Serono division has announced that the Australian Therapeutic Goods Administration has given the green light to Movectro (cladribine) for the treatment of relapsing-remitting MS "for a maximum duration of two years. The drug was granted its first approval in Russia in July, making it the first oral MS treatment in the world to gain marketing authorisation.
Merck Serono president Elmar Schnee, noting that Australia is the second country to approve the pill, said that "we will continue our efforts to gain approval of cladribine tablets in other countries so that more patients can benefit from this oral disease-modifying therapy". The treatment has been filed in around 40 countries and was resubmitted to the US Food and Drug Administration in June, seven months after receiving a 'refuse to file' letter from the agency.
Movectro will be competing intially with Novartis' fingolimod, which was recommended for approval by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee in June. Although the Australian market is relatively small, getting the thumbs-up for cladribine there may help in getting other regulators to follow suit.