It was a relatively quieter week for the pharma sector. The FDA approved Glaxo’s (
GSK Quick Quote GSK - Free Report) Nucala, Pfizer’s ( PFE Quick Quote PFE - Free Report) Xeljanz and J&J’s ( JNJ Quick Quote JNJ - Free Report) Simponi Aria for new indications. Recap of the Week’s Most Important Stories The FDA granted approval to Glaxo’s drug Nucala for the third indication — FDA Approves Glaxo’s Nucala for 3rd Indication: hypereosinophilic syndrome (HES) — a rare disease caused by eosinophilic inflammation. Nucala, an anti-IL5 biologic, is presently marketed for eosinophil-driven diseases like severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis. The FDA also approved Pfizer’s blockbuster JAK inhibitor Xeljanz as well as J&J’s Simponi Aria for the treatment of children 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). This is FDA Approves Pfizer’s Xeljanz & J&J’s Simponi Aria for Juvenile Arthritis: the fourth indication for which Xeljanz is now approved, the other three being rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ulcerative colitis. Xeljanz was approved for the pcJIA indication in two formulations, a tablet (5 mg) and oral solution.
The FDA also expanded Simponi Aria’s active psoriatic arthritis indication use for pediatric patients 2 years and older. Simponi Aria is presently approved for RA, active PsA and ankylosing spondylitis in adults.
J&J also filed a new drug application seeking approval of its pulmonary arterial hypertension (PAH) drug Uptravi as an injection for intravenous (IV) use in patients who are unable to take the currently marketed oral formulation of the drug. The NDA was based on data from a phase III study, which evaluated safety and tolerability of temporarily switching from oral Uptravi to Uptravi IV in patients with PAH, and then transitioning back to the initial oral dose. J&J Files NDA for Injection Formulation of Uptravi: The FDA granted Orphan Drug and Fast Track designations to AbbVie’s ( FDA Grants AbbVie’s CNS Candidate Fast Track and Orphan Status: ABBV Quick Quote ABBV - Free Report) pipeline candidate, elezanumab for the treatment of spinal cord injury. Elezanumab, a monoclonal antibody RGMa inhibitor, is presently being evaluated in a phase II study for spinal cord injury. Separately, it is also being studied for other neurological disorders like multiple sclerosis and acute ischemic stroke
The NYSE ARCA Pharmaceutical Index rose 1.13% in the last five trading sessions.
Here is how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, J&J recorded the maximum increase (3%) while Roche (
RHHBY Quick Quote RHHBY - Free Report) declined the most (4.6%).
In the past six months, AstraZeneca (
AZN Quick Quote AZN - Free Report) has risen the most (25.3%) while Novartis ( NVS Quick Quote NVS - Free Report) recorded the minimum increase (4%).
(See the last pharma stock roundup here:
J&J’s Coronavirus Vaccine in Phase III, Other Updates) What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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