Drugs in the Pipeline

Tezepelumab Gets Breakthrough Therapy Designation for Severe Asthma

Tezepelumab Gets Breakthrough Therapy Designation for Severe Asthma

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.

RET Inhibitor Gets Breakthrough Tx Status for NSCLC, Medullary Thyroid Cancer

RET Inhibitor Gets Breakthrough Tx Status for NSCLC, Medullary Thyroid Cancer

LOXO-292 is being evaluated in the ongoing Phase 1/2 LIBRETTO-001 clinical trial.

Oral JAK3 Inhibitor Granted Breakthrough Tx Designation for Alopecia Areata

Oral JAK3 Inhibitor Granted Breakthrough Tx Designation for Alopecia Areata

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.

Anti-Nicotine Monoclonal Antibody Gets Orphan Drug Status for Buerger's Disease

Anti-Nicotine Monoclonal Antibody Gets Orphan Drug Status for Buerger's Disease

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.

Gene Therapy for Localized Scleroderma Gets FDA's Fast Track Designation

Gene Therapy for Localized Scleroderma Gets FDA's Fast Track Designation

Clinical enrollment for an open-label, single-arm Phase 1/2 trial of FCX-013 was initiated in August 2018.

Trial Evaluating BCG Vaccine for Fibromyalgia Given Green Light by FDA

Trial Evaluating BCG Vaccine for Fibromyalgia Given Green Light by FDA

The investigators hope that the BCG vaccine can increase anti-inflammatory cytokines, which are deficient in patients with fibromyalgia.

Doptelet sNDA Submitted to FDA for Treatment of Immune Thrombocytopenia

Doptelet sNDA Submitted to FDA for Treatment of Immune Thrombocytopenia

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.

Esketamine Nasal Spray NDA Submitted to FDA for Treatment-Resistant Depression

Esketamine Nasal Spray NDA Submitted to FDA for Treatment-Resistant Depression

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.

Keytruda Gets Priority Review for Merkel Cell Carcinoma Indication

Keytruda Gets Priority Review for Merkel Cell Carcinoma Indication

Merkel cell carcinoma is a rare form of skin cancer associated with higher mortality rates than other skin cancers.

FDA Rejects ADHD Drug NDA Citing Need for More Data

FDA Rejects ADHD Drug NDA Citing Need for More Data

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.

Novel Epinephrine Nasal Spray for Anaphylaxis Gets Fast Tracked by FDA

Novel Epinephrine Nasal Spray for Anaphylaxis Gets Fast Tracked by FDA

The bioavailability of the novel epinephrine nasal spray also proved similar to that of intramuscular injection with EpiPen 0.3mg injection.

FDA to Review Sprycel as Add-On to Chemotherapy in Pediatric Ph+ ALL

FDA to Review Sprycel as Add-On to Chemotherapy in Pediatric Ph+ ALL

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.

Resubmitted Duobrii Lotion NDA for Plaque Psoriasis Accepted

Resubmitted Duobrii Lotion NDA for Plaque Psoriasis Accepted

Its long-term safety was evaluated in a phase 3, multicenter, open-label study of 555 adults with moderate to severe plaque psoriasis.

FDA Issues CRL Rejecting Waylivra Approval for Familial Chylomicronemia Syndrome

FDA Issues CRL Rejecting Waylivra Approval for Familial Chylomicronemia Syndrome

"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.

Elagolix + Add-Back Tx Reduces Heavy Menstrual Bleeding in Phase 3 Extension Study

Elagolix + Add-Back Tx Reduces Heavy Menstrual Bleeding in Phase 3 Extension Study

AbbVie plans to submit data from the phase 3 uterine fibroids program to the FDA sometime in 2019.



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