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Monthly News Roundup - August 2019

AbbVie’s Rinvoq Approved for Rheumatoid Arthritis

This month, the FDA approved AbbVie's Rinvoq (upadacitinib), an oral, 15 mg, once-daily Janus kinase (JAK) inhibitor for adults with moderate-to-severe rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).

  • In the SELECT Phase 3 studies, roughly 4,400 patients were evaluated. Across all treatment arms in five studies, Rinvoq met all primary and ranked secondary endpoints.
  • In SELECT-COMPARE, 71% of MTX-IR patients treated with Rinvoq 15 mg plus MTX achieved ACR20 (a composite measure that captures at least a 20% RA improvement) compared to 36% treated with placebo plus MTX at week 12.
  • Common side effects included upper respiratory tract infections (common cold, sinus infections), nausea, cough, and pyrexia (fever).

Xenleta, a First-in-Class Agent Cleared for Bacterial Pneumonia 

Macrolides and fluoroquinolones are options for treatment of community-acquired bacterial pneumonia (CABP) but have limitations due to resistance and safety concerns, respectively.

  • In August, the FDA cleared Nabriva’s Xenleta (lefamulin) for the treatment of community-acquired bacterial pneumonia (CABP) in adults. Xenleta is a first-in-class, semi-synthetic pleuromutilin antibiotic.
  • Phase 3 studies in 1,289 patients showed comparable efficacy of Xenleta with moxifloxacin, with or without linezolid, over 5 to 7 days, as well as with 7-day oral moxifloxacin monotherapy, using 5 days of therapy for Xenleta.
  • Xenleta is available for oral (600 mg every 12 hours) and IV (150 mg every 12 hours) administration with a short 5-to-7 day course of therapy.
  • Common side effects for oral therapy include: diarrhea, nausea, vomiting, and liver enzyme elevation; IV therapy includes injection site reactions, liver enzyme elevation, nausea, low potassium, insomnia, and headache.

Wakix: First-in-Class Agent for Narcolepsy is Not a Controlled Substance

Harmony Biosciences announced that the FDA has approved once-daily oral Wakix (pitolisant), a histamine-3 (H₃) receptor antagonist/inverse agonist for the treatment of excessive daytime sleepiness (EDS) in adults with narcolepsy. 

  • Wakix is the first treatment for narcolepsy that is not a controlled substance. Wakix works by increasing the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain.
  • In two eight-week, placebo-controlled Phase 3 studies with 261 patients, Wakix showed a significant effect in EDS measured by the Epworth Sleepiness Scale (ESS) score.
  • Common side effects are insomnia (6%), nausea (6%), and anxiety (5%).
  • Wakix will be commercially available in Q4 2019.

Learn More: 10 Common Sleep Disorders: Treatments & Truths

Genentech’s Rozlytrek Approved to Target ROS1 NSCLC and NTRK Gene Fusion Tumors

Rozlytrek (entrectinib) has received FDA accelerated approval for the treatment of patients with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). It is also cleared for neurotrophic tyrosine receptor kinase (NTRK) gene fusion-positive solid tumors (for example: breast cancer, colorectal cancer, or pancreatic tumors, among others). Rozlytrek is classified as a selective tyrosine kinase inhibitor and is used with genomic testing.

  • In ROS1-positive, metastatic NSCLC, Rozlytrek reduced tumor size in 78% of people with a duration of response from 1.8 to 36.8+ months.
  • Rozlytrek also lessened tumor size in over 50% of those with NTRK gene fusion-positive, locally advanced or metastatic solid tumors.
  • Common side effects (≥ 20%) include: fatigue, constipation, dysgeusia (altered taste), vomiting, edema, dizziness, and diarrhea, among others.

FDA Clears Pretomanid Tablets for Treatment-Resistant Tuberculosis (TB)

In August, the FDA approved oral pretomanid tablets, a nitroimidazooxazine antimycobacterial, in combination with bedaquiline (Sirturo) and linezolid (Zyvox) for the treatment of adults with extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) pulmonary tuberculosis (TB).

  • MDR TB and XDR TB are difficult to treat due to resistance to available drug options.
  • In a study evaluating the safety and effectiveness of the pretomanid tablet regimen, 95/107 patients (89%) had success, which significantly exceeds the historical success rates for treatment of XDR TB.
  • Common side effects may include nerve damage (peripheral neuropathy), acne, anemia, nausea, vomiting, headache, increased liver enzymes, indigestion (dyspepsia), and rash, among others.
  • Approval was granted to The Global Alliance for TB Drug Development. 

Learn More: Which Bacteria Are Resistant to Antibiotics? The Top 10 List

Posted: August 2019