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FDA New Drug Approvals in Q3 2019 Market Leader for Myelofibrosis

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FDA New Drug Approvals in Q3 2019 Market Leader for Myelofibrosis NEWS & ANALYSIS been reported for Inrebic, which could be MARKET WATCH considered when making comparisons with Incyte’s Jakafi (ruxolitinib), the current FDA new drug approvals in Q3 2019 market leader for myelofibrosis. Of the raft of oncology products greenlighted by the FDA, Roche’s Rozlytrek The biggest approval of the third quarter was for rheumatoid arthritis. AbbVie had (entrectinib) for cancers with NTRK fusions not a new drug, but an oral version of Novo been hoping to avoid the safety issues that is perhaps the most interesting, as another Nordisk’s semaglutide, branded Rybelsus, have dogged older JAK inhibitors such as tumour- agnostic approval and because of which has a consensus sales forecast of Pfizer’s Xeljanz (tofacitinib), which were Roche’s decisions on pricing. In an attempt $3.3 billion in 2024. Rybelsus is entering a thought to be due to targeting both JAK1 to take on rival Vitrakvi (larotrectinib; crowded field with over six other glucagon- and JAK2, but still received a black-box Loxo/Bayer), Rozlytrek’s list price is $17,000 like peptide 1 receptor agonists already warning for thrombosis on its label. a month, compared with $33,000 per month approved, including Novo’s once-weekly This could limit its sales, although these for Vitrakvi. Roche is also focusing on injectable version of semaglutide, Ozempic. are nevertheless forecast to exceed $3 billion Rozlytrek’s additional approval in ROS1- The success of Rybelsus will be determined by 2024 (Table 1). positive non-small-cell lung cancer as a by its price and whether it also gains a label The other JAK inhibitor approved in differentiator. In addition, the agency granted for reduction of cardiovascular risk, for which the quarter, Celgene’s Inrebic (fedratinib) approval to Karyopharm Therapeutics’ trial results are due in January 2020. for myelofibrosis, also received a black- Xpovio (selinexor), a nuclear export The other big-ticket approval of the box warning, potentially threatening its inhibitor, in combination with steroids quarter was AbbVie’s Rinvoq (upadacitinib), previously lofty sales forecasts. Hepatic for the treatment of relapsed or refractory a selective Janus kinase 1 (JAK1) inhibitor and gastrointestinal toxicities have also multiple myeloma and Daiichi Sankyo’s Turalio (pexidartinib hydrochloride) for tenosynovial giant cell tumours. Table 1 | Selected FDA new drug approvals in Q3 2019 Finally, Bayer’s Nubeqa (darolutamide), Date Drug (brand name; Properties Indication 2024 global a non-steroidal androgen receptor inhibitor, company) sales forecast gained approval for non-metastatic 3 Jul Selinexor (Xpovio; XPO1 inhibitor Multiple myeloma 599 million castration-resistant prostate cancer. Karyopharm The need to find new antibacterial Therapeutics) drugs saw both Xenleta (lefamulin; Nabriva 16 Jul Cilastatin; imipenem; Bacterial PBP Urinary tract and NA Therapeutics) and Merck and Co’s Recarbrio relebactam (Recarbrio; inhibitor ; intra- abdominal (a combination of imipenem, cilastatin and Merck & Co.) -lactamase inhibitor bacterial infections β the new β-lactamase inhibitor relebactam) 25 Jul Ferric maltol (Accrufer ; Haemoglobin Iron deficiency 176 million granted fast- track designation and approved Shield Therapeutics) regulator under the FDA’s Qualified Infectious 30 Jul Darolutamide (Nubeqa; Androgen receptor Non- metastatic 637 million Disease Product designation. Xenleta is a Bayer/Orion) antagonist CRPC first- in-class semisynthetic pleuromutilin 2 Aug Pexidartinib (Turalio; CSF1R/KIT/FLT3 Tenosynovial giant 164 million antibiotic for community-acquired bacterial Daiichi Sankyo) inhibitor cell tumour pneumonia (CABP). An estimated 1 million 14 Aug Pitolisant hydrochloride Histamine H3 Narcolepsy NA people in the US are hospitalised with CABP, (Wakix; Harmony receptor inverse and Xenleta’s low toxicity could make it a Biosciences) agonist more appealing option than established 14 Aug Pretomanid (NA ; Unclassified Tuberculosis NA antibiotics. However, given that these are Novartis/TB Alliance) cheaper, Xenleta could face slow uptake, 15 Aug Entrectinib (Rozlytrek; ALK/ROS1/TRK NTRK- positive solid 342 million and the current consensus sales forecast for Roche) inhibitor tumours; metastatic 2024 is $259 million. NSCLC Another first- in-class approval was 16 Aug Fedratinib (Inrebic; JAK2 inhibitor Myelofibrosis 378 million Harmony Biosciences’ Wakix (pitolisant), Celgene) a selective histamine H3 receptor inverse 16 Aug Upadacitinib (Rinvoq; JAK1 inhibitor Rheumatoid 3,054 million agonist, for the treatment of excessive AbbVie) arthritis daytime sleepiness in adults with narcolepsy. 19 Aug Lefamulin (Xenleta; PTC inhibitor Community- 259 million Finally, also in the central nervous system Nabriva Therapeutics) acquired bacterial area, Kyowa Kirin’s Nourianz (istradefylline), pneumonia a selective adenosine A2A receptor antagonist, 27 Aug Istradefylline (Nouriast; Adenosine A2A Parkinson disease 142 million was approved as an add-on treatment to Kyowa Kirin) receptor antagonist levodopa for patients with Parkinson disease. 12 Sep Tenapanor (Ibsrela; NHE3 inhibitor IBS with 694 million Lisa Urquhart Ardelyx) constipation Vantage, London, UK. ALK , anaplastic lymphoma kinase; CRPC, castration- resistant prostate cancer ; CSF1R , macrophage colony *e- mail: [email protected] stimulating factor receptor 1; FLT3, FMS- like tyrosine kinase 3; IBS, irritable bowel syndrome; JAK , Janus https://doi.org/10.1038/d41573-019-00177-7 kinase; NHE3, sodium–hydrogen exchanger 3; NA ; not available; NSCLC, non- small-cell lung cancer ; PBP, penicillin- binding protein; PTC, peptidyl transferase centre; TRK , tropomyosin receptor kinase; Competing interests XPO, exportin. EvaluatePharma October 2019, Evaluate Ltd. The author declares no competing interests. 816 | NOVEMBER 2019 | VOLUME 18 www.nature.com/nrd.
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