{ "docId": "019dd923-622c-750b-8b9a-21918ac10c17", "docSlug": "f3db2294dcf9", "documentTitle": "Harmony Biosciences (HRMY)", "authorId": "58_Scorpion_Capital", "authorName": "Scorpion Capital", "documentKindSlug": "research-note", "documentKindLabel": "Research note", "sourceTypeSlug": "short_seller", "sourceTypeLabel": "Short seller", "presentationDate": "2023-03-28 00:00:00", "orientation": "landscape", "aspectRatio": 1.3333334, "pageNumber": 191, "pageCount": 366, "prevPage": 190, "nextPage": 192, "slideType": "other", "function": "illustrate_case", "density": "dense", "nDataPoints": 0, "notes": "The slide highlights a discrepancy between patient belief and sponsor assessment regarding drug causality.", "elementsJson": [ "headline_text", "paragraph", "footnote" ], "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/191", "deckHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json", "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-191", "components": [ { "bbox": null, "kind": "callout", "text": "Event was assessed as not related to pitolisant – case report doesn't provide the rationale.", "attrs": null, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd953-64d1-73a9-abba-b10560f99294", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.11 }, "kind": "paragraph", "text": "After two weeks on pitolisant, a 71-year old male patient went to the emergency room with 104 degree fever, “explosive diarrhea”, and chills and was hospitalized. Lab tests revealed “elevated liver enzymes” and “elevated bilirubin of unknown etiology” – “however, it was determined that the patient did not have any type of infection.” The patient was discharged and hospitalized again a day later. A CT scan revealed “two pulmonary emboli in the right lower lobe of his lung.” The report suggests that the patient believed that the emboli were associated with pitolisant but that “nobody” believed him. Event was assessed as not related to pitolisant – case report doesn’t provide the rationale.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "5eb57ea1-72d6-4547-8588-b6394d3022f4", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.48, "w": 0.86, "x": 0.07, "y": 0.41 }, "kind": "paragraph", "text": "Event/Problem Narrative: On 01-OCT-2021 and 07-OCT-2021, a spontaneous report and follow-up information were received from a consumer describing a 71-year-old male who was being treated with WAKIX (pitolisant). Medical history and concomitant medications were not provided. On (b)(6)*****, after starting WAKIX and during the second week of titration (dose was 17.8 mg/day at the time), the patient went to the Emergency Room (ER) with complaints of fever of 103.9 degrees Fahrenheit (F), two bouts of explosive diarrhea and chills. The patient was subsequently admitted for further work-up. Laboratory results revealed elevated liver enzymes and bilirubin (values were not provided). Treatment was not provided; however, it was determined that the patient did not have any type of infection. The cause of the elevated liver enzymes and bilirubin were not provided. The patient was discharged to home on (b)(6)*****. He reported that he did not receive WAKIX while in the hospital and denied any withdrawal symptoms. On (b)(6)*****, the patient returned to the ER with complaints of fever, chills, severe back pain and bilateral flank pain. A Computed Tomography (CT) scan revealed two pulmonary emboli in the right lower lobe of his lung. The patient was readmitted to the hospital and treatment with Eliquis (apixaban) was initiated (dose/frequency not provided). The patient reported that \"nobody\" (presumed to mean those involved in his care) believed the pulmonary emboli were associated with WAKIX. On (b)(6)*****, treatment with WAKIX was resumed at 35.6 mg, 1x/day. On(b)(6)*****, the patient was discharged to home. On 07-OCT-2021, the patient reported he was feeling better and improving. Follow-up information has been requested. Sponsor's Assessment: A 71-year-old male, treated with WAKIX, was hospitalized for a high fever, diarrhea, chills, elevated liver enzymes, and elevated bilirubin of unknown etiology, as infectious etiology was ruled out. The patient was readmitted one day following discharge with severe back pain and bilateral flank pain, at which time a diagnosis of pulmonary emboli was made. Following discharge after his readmission, the events were reported as improving while treatment with WAKIX was resumed. Although precluded by a lack of information regarding medical history and concomitant medication usage, the pulmonary emboli, fever, diarrhea, chills, elevated liver enzymes, elevated bilirubin, and flank and back pain were assessed as not related to WAKIX.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "82fadd23-7c27-4a58-9eff-9d42b27514b5", "frameworkName": null, "frameworkSlug": null }, { "bbox": null, "kind": "quote", "text": "The report suggests that the patient believed that the emboli were associated with pitolisant but that \"nobody\" believed him.", "attrs": null, "subkind": null, "toolName": "Authority citation", "toolSlug": "authority-citation", "confidence": null, "componentId": "019dd953-64d1-73a9-abba-b466d4716469", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: FDA FAERS – FOIA Case Report Information", "attrs": null, "subkind": null, "toolName": null, "toolSlug": null, "confidence": null, "componentId": "129ce277-ce3b-40e5-b4e0-cb04cdf734b2", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.03, "w": 0.45, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "Case ID: 19955229, Event date: 2021", "attrs": null, "subkind": "headline", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "a878bc89-f9c4-4edf-b106-5233ceae998e", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }