EndeavorRx screen (Akili Interactive)

FDA ap­proves first ther­a­peu­tic video game

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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Sekar Kathiresan, Verve Therapeutics CEO

Verve re­veals let­ter from FDA that lays out con­di­tions to lift base edit­ing tri­al hold

We now know why Verve’s lead candidate was placed on hold last month by US regulators.

In an SEC filing, Verve laid out the FDA’s conditions for lifting the hold on its lead therapy, VERVE-101. That includes submitting preclinical data about potency differences in human versus non-human cells, risks of gene editing germline cells, and off-target analyses in non-hepatocyte cell types.

The FDA also wants clinical data from the ongoing Heart-1 trial, and to modify the trial protocol in the US to add additional contraceptive measures and increase the length of a staggering interval between the dosing of participants.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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