Here’s a new one: The FDA has just ap­proved a pre­scrip­tion video game.

The brain­child of a cou­ple of cog­ni­tive sci­en­tists who built the pro­to­type tech­nol­o­gy over a decade ago, the video game is de­signed to help im­prove at­ten­tion func­tion in kids with AD­HD. It was de­vel­oped by Ak­ili In­ter­ac­tive, one of two ma­jor health tech video game com­pa­nies, and is called En­deav­or­Rx.

Doc­tors can pre­scribe it for kids ages 8 to 12 with AD­HD and a his­to­ry of at­ten­tion is­sues. A price has yet to be an­nounced, but an Ak­ili spokesper­son said in an email that they are work­ing to get cov­er­age from in­sur­ers and to “ex­pect pric­ing to be in the range of oth­er treat­ments like drugs and be­hav­ioral ther­a­py cur­rent­ly used in chil­dren with AD­HD.”

Adam Gaz­za­ley

The ap­proval is the cul­mi­na­tion of a years-long ef­fort to con­vince reg­u­la­tors that a video game could even be a pre­scrip­tion ther­a­py. Ak­ili was found­ed in 2011, with tech­nol­o­gy li­censed from Adam Gaz­za­ley’s lab at the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co, and got ear­ly back­ing from Pfiz­er, Shire and PureTech, among oth­ers. (Pear Ther­a­peu­tics, the oth­er ma­jor com­pa­ny in the space, was found­ed 2 years lat­er.) The idea was that, with the right al­go­rithms, a game could re­train neur­al net­works and help peo­ple with cer­tain cog­ni­tive dis­or­ders mul­ti­task, fo­cus, and process in­for­ma­tion.

Even as they test­ed the soft­ware in Alzheimer’s, AD­HD, de­pres­sion and autism, they en­coun­tered skep­ti­cism about the po­ten­tial im­pact. A 2013 meta-analy­sis an­a­lyzed 46 ex­per­i­ments on video games, and found they pro­duced “neg­li­gi­ble ef­fects for ex­ec­u­tive func­tion.” Ak­ili first asked for FDA ap­proval in mid-2018. For drugs, at least, a de­ci­sion gen­er­al­ly comes with­in 10 months.

En­deav­or­Rx was fi­nal­ly ap­proved based on 5 clin­i­cal tri­als, in­clud­ing a study pub­lished on April 1 in The Lancet Dig­i­tal Health that found that 25 min­utes of game play per day, 5 days a week, for 4 weeks “might be used to im­prove ob­jec­tive­ly mea­sured in at­ten­tion in pe­di­atric pa­tients with AD­HD.” It was cleared un­der the FDA’s De No­vo pro­gram for a new type of low- or mod­er­ate-risk de­vice.

Al­though on­ly ap­proved to­day, the game has ac­tu­al­ly been avail­able for over a month. In April, the FDA re­laxed reg­u­la­tions for low-risk men­tal health de­vices, and Ak­ili launched a site that al­lowed chil­dren to get the game for free for up to three months.

The game sends kids through land­scapes teem­ing with la­va or ice, or on un­der­wa­ter mis­sions, and re­wards them for com­plet­ing var­i­ous tasks.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.