Drugs in the Pipeline
The designation was based on data from the Phase 2b PATHWAY trial that evaluated 3 doses of tezepelumab as add-on therapy in patients with a history of asthma exacerbations and uncontrolled asthma receiving inhaled corticosteroids/long-acting β-agonist with or without oral corticosteroids and additional asthma controllers vs placebo.
LOXO-292 is being evaluated in the ongoing Phase 1/2 LIBRETTO-001 clinical trial.
PF-06651600 is an investigational oral Janus kinase 3 (JAK3) inhibitor that is being evaluated in a Phase 2 study which will assess the treatment based on changes from baseline in Severity of Alopecia Tool (SALT) score.
Buerger's disease is a nonatherosclerotic, segmental inflammatory disorder that affects small and medium vessels of the upper and lower extremities and is strongly associated with tobacco exposure.
Clinical enrollment for an open-label, single-arm Phase 1/2 trial of FCX-013 was initiated in August 2018.
The investigators hope that the BCG vaccine can increase anti-inflammatory cytokines, which are deficient in patients with fibromyalgia.
The sNDA includes safety and efficacy data from a Phase 3, randomized, placebo-controlled trial that met its primary efficacy endpoint of number of weeks with a platelet count ≥50x109/L in the absence of rescue therapy with high statistical significance.
The NDA includes five Phase 3 studies in patients with treatment-resistant depression: 3 short-term studies, 1 withdrawal maintenance of effect study, and 1 long-term safety study.
Merkel cell carcinoma is a rare form of skin cancer associated with higher mortality rates than other skin cancers.
The FDA stated that the dasotraline NDA cannot be approved in its current form and is requiring additional data to further assess the efficacy and tolerability of the drug.
The bioavailability of the novel epinephrine nasal spray also proved similar to that of intramuscular injection with EpiPen 0.3mg injection.
The sBLA contains data from the Phase 2 CA180-372 trial evaluating Sprycel as an add-on to chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL.
Its long-term safety was evaluated in a phase 3, multicenter, open-label study of 555 adults with moderate to severe plaque psoriasis.
"We are extremely disappointed with the FDA's decision. We continue to feel strongly that Waylivra demonstrates a favorable benefit/risk profile in people with FCS," said Akcea CEO, Paula Soteropoulos.
AbbVie plans to submit data from the phase 3 uterine fibroids program to the FDA sometime in 2019.
NEPHROLOGY & UROLOGY NEWS
- Acute Kidney Injury (AKI)
- Chronic Kidney Disease (CKD)
- Contrast Nephropathy
- Cardiovascular Disease (CVD)
- Diabetic Nephropathy
- End-stage Renal Disease (ESRD)
- Lupus Nephritis
- Peritoneal Dialysis
- Secondary Hyperparathyroidism (SHPT)