{"id":90124,"date":"2019-11-18T14:34:59","date_gmt":"2019-11-18T14:34:59","guid":{"rendered":"https:\/\/clarivate.com\/cortellis\/?p=40053"},"modified":"2024-10-24T00:27:08","modified_gmt":"2024-10-24T00:27:08","slug":"expected-blockbusters-a-year-in-progress","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/blog\/expected-blockbusters-a-year-in-progress\/","title":{"rendered":"Expected blockbusters: A year in progress"},"content":{"rendered":"

Earlier this year, we released the Cortellis Drugs to Watch 2019 report<\/a>, which highlighted seven drugs expected to launch in 2019 and become blockbusters in 2023. We have subsequently reported on three of those drugs that have now gained approval<\/a>, including Zolgensma which entered the market as the most expensive drug ever launched. Since that time, Rinvoq (upadacitinib) has been approved and launched in the U.S.; Ultomiris has been launched in the EU and Japan and received additional U.S. approval for a second indication; and Evrenzo (roxadustat) has been approved in Japan and its label expanded in China. Meanwhile, Palforzia (AR-101) has faced some delays and its regulatory filing is still under FDA evaluation. 1-8<\/sup><\/p>\n

 <\/p>\n

Rinvoq launches in the U.S. and gets positive CHMP opinion<\/strong><\/p>\n

Rinvoq, AbbVie\u2019s oral JAK1-selective inhibitor, received U.S. approval in rheumatoid arthritis (RA) in August 2019, launching shortly after.1,2<\/sup> Rinvoq has demonstrated remarkable efficacy in a wide range of RA settings, achieving all primary and ranked secondary endpoints in the phase III SELECT program. By leveraging these data, in particular,\u00a0 superior efficacy to best-in-class Humira, Rinvoq stands to gain a substantial share of the crowded RA market.1<\/sup><\/p>\n

The product is also being reviewed for approval in Japan and the EU, with the EMA\u2019s Committee for Medicinal Products for Human Use (CHMP) adopting a positive opinion in October 2019.9<\/sup>\u00a0 The Cortellis Analytics \u2013 Drug Timeline & Success Rates tool<\/a> forecasts EU approval in December 2019 and Japan approval in June 2020, with a likelihood of success of 95% for both regions.<\/p>\n

 <\/p>\n

Ultomiris now available in multiple markets<\/strong><\/p>\n

Alexion Pharmaceuticals received Japanese and EU approval for its complement inhibitor Ultomiris in June and July 2019, respectively, followed by launches in those regions.3, 4<\/sup> Ultomiris is a next-generation follow-on to Alexion\u2019s market-leading Soliris for paroxysmal nocturnal hemoglobinuria, a rare and progressive blood disorder that is fatal in approximately 50% of cases. Ultomiris has the potential to become the new standard of care over Soliris by leveraging its non-inferiority and greatly improved dosing convenience (every eight weeks versus every two weeks).10<\/sup><\/p>\n

Ultomiris also received additional U.S. approval in October 2019 for atypical hemolytic uremic syndrome (aHUS), an ultra-rare disease that causes progressive kidney failure and can lead to death. Ultomiris is also set to replace Soliris in this setting.5<\/sup> Filings for aHUS in the EU and Japan are also being reviewed, with the Cortellis Drug Timeline & Success Rates tool<\/a> forecasting a 95% likelihood of approval in mid-2020 for both regions.<\/p>\n

 <\/p>\n

Evrenzo gets approval in Japan for anemia with CKD and secures label expansion China<\/strong><\/p>\n

AstraZeneca\/FibroGen\/Astellas\u2019 Evrenzo, a first-in-class oral HIF-PH inhibitor, received Japanese approval in September 2019 for anemia in chronic kidney disease (CKD) patients on dialysis.6<\/sup> In Mainland China, a label expansion to include non-dialysis-dependent patients was approved in August 2019.7<\/sup><\/p>\n

In the U.S. and EU, submissions for both dialysis-dependent and dialysis-independent patients are being prepared.11<\/sup> Evrenzo showed no increased risk in major cardiovascular events compared with epoetin alfa in a pooled safety analysis required by the FDA and the EMA.12<\/sup> The Cortellis Drug Timeline & Success Rates tool<\/a> forecasts a 90% chance of approval for both regions.<\/p>\n

 <\/p>\n

Palforzia moves closer to approval despite delays<\/strong><\/p>\n

Palforzia, Aimmune Therapeutics\u2019 oral desensitization immunotherapy for peanut allergy, is under review for U.S. approval. Two setbacks have delayed the drug\u2019s potential market entry: The U.S. government shutdown in December 2018\/January 2019 and the FDA decision to consider Palforzia an allergenic product candidate and therefore not eligible for expedited review associated with its Fast Track and Breakthrough Therapy designations.8<\/sup> Despite discussions with the FDA, the filing was given a 12-month target period with an action date expected in late January 2020. However, Palforzia is now closer to becoming the first FDA-approved therapy for peanut allergy, following a positive recommendation from the Allergenic Products Advisory Committee (APAC) in September 2019.13<\/sup><\/p>\n

In the EU, a filing was submitted in June 2019 and is currently under review.14<\/sup> \u00a0The Cortellis Drug Timeline & Success rates tool<\/a> forecasts a 95% probability of approval, in October 2020.<\/p>\n

 <\/p>\n

Conclusion<\/strong><\/p>\n

Our analysis in the Cortellis Drugs to Watch 2019 report identified seven drugs expected to launch this year with sales forecasts of $1 billion or more by 2023. The four products discussed above provide a fascinating picture of the latest trends in the pharmaceutical industry, giving examples of drugs successfully entering highly crowded markets, of new treatments being approved for rare diseases, and of cutting-edge science being used to develop products capable of monopolizing whole new markets.<\/p>\n

Click here<\/a> to read the full report: Cortellis Drugs to Watch.<\/strong><\/p>\n

 <\/p>\n

References<\/strong><\/p>\n

    \n
  1. https:\/\/news.abbvie.com\/news\/press-releases\/abbvie-receives-fda-approval-rinvoq-upadacitinib-an-oral-jak-inhibitor-for-treatment-moderate-to-severe-rheumatoid-arthritis.htm<\/li>\n
  2. https:\/\/www.rinvoqhcp.com\/access-and-support#commercial<\/li>\n
  3. https:\/\/news.alexionpharma.com\/press-release\/product-news\/ultomiris-ravulizumab-receives-marketing-authorization-european-commissio<\/li>\n
  4. https:\/\/alexionpharma.jp\/press_release\/Press-2019-9-4_Ultomiris_PNH_Japan_Launch_FF.aspx<\/li>\n
  5. https:\/\/www.biospace.com\/article\/releases\/alexion-receives-fda-approval-for-ultomiris-ravulizumab-cwvz-for-atypical-hemolytic-uremic-syndrome-ahus-\/<\/li>\n
  6. https:\/\/www.prnewswire.com\/news-releases\/evrenzo-roxadustat-tablets-approved-in-japan-for-the-treatment-of-anemia-associated-with-chronic-kidney-disease-in-dialysis-patients-300922278.html<\/li>\n
  7. https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2019\/roxadustat-approved-in-china-for-the-treatment-of-anaemia-in-non-dialysis-dependent-patients-with-chronic-kidney-disease-22082019.html<\/li>\n
  8. Form 8-K \u2013 Aimmune Therapeutics Inc (16\/01\/19)<\/li>\n
  9. https:\/\/news.abbvie.com\/news\/press-releases\/abbvie-receives-chmp-positive-opinion-for-upadacitinib-rinvoq-for-treatment-adults-with-moderate-to-severe-active-rheumatoid-arthritis.htm<\/li>\n
  10. Form 8-K – Alexion Pharmaceuticals Inc (21\/12\/18)<\/li>\n
  11. https:\/\/www.globenewswire.com\/news-release\/2019\/09\/26\/1921146\/0\/en\/FibroGen-Announces-Initiation-of-Phase-2-Clinical-Trial-of-Roxadustat-for-the-Treatment-of-Anemia-in-Cancer-Patients-Receiving-Chemotherapy.html<\/li>\n
  12. https:\/\/www.globenewswire.com\/news-release\/2019\/05\/09\/1821450\/0\/en\/FibroGen-Announces-Positive-Topline-Results-from-Pooled-Safety-Analyses-of-Roxadustat-Global-Phase-3-Program.html<\/li>\n
  13. https:\/\/www.businesswire.com\/news\/home\/20190913005515\/en\/FDA-Allergenic-Products-Advisory-Committee-Votes-Support<\/li>\n
  14. https:\/\/www.biospace.com\/article\/releases\/aimmune-therapeutics-announces-second-quarter-2019-financial-results-and-provides-operational-highlights\/<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

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