U.S. Regulatory News August 2018

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News of FDA drug approvals and orphan drug designations for humans and animals.

Source: Bloomberg BNA (reports from July 16 and 23, 2018) and the Food and Drug Administration website. Compiled by Linda C. Brown, managing editor.

HUMAN |
ANIMAL

 

HUMAN

Company Trade Name Generic Name Action

Acceleron

ACE-083

FDA granted orphan drug designation for treatment of patients with facioscapulohumeral muscular dystrophy.

Advaxis Inc.

axalimogene filolisbac in combination with durvalumab

FDA lifted clinical hold on Phase 1/2 combination study for the treatment of patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer.

Agios Pharmaceuticals Inc.

Tibsovo

ivosidenib

FDA approved Tibsovo for the treatment of adult patients with relapsed or refractory acute myeloid leukemia who have a specific genetic mutation.

Asceneuron SA

ASN120290

FDA granted orphan drug designation for the treatment of progressive supranuclear palsy.

Astellas Pharma Inc. and Pfizer Inc.

Xtandi

enzalutamide

FDA approved expanded use for the treatment of men with non-metastatic castration-resistant prostate cancer.

Bristol-Myers Squibb Co.

Intravenous Opdivo plus Yervoy

nivolumab plus ipilimumab

FDA approved the drug product for the treatment of patients with previously treated microsatellite instability-high or DNA mismatch repair deficient metastatic colorectal cancer.

Cellectar Biosciences 

CLR 131

FDA granted orphan drug designation for treatment of Ewing sarcoma.

Eagle Pharmaceuticals Inc. 

Bendeka

bendamustine hydrochloride injection, or bendamustine HCI

FDA granted seven year orphan drug exclusivity for the treatment of chronic lymphocytic leukemia and slow-growing non-Hodgkin lymphoma.

Gamida Cell

NiCord

FDA granted orphan drug designation for the treatment for hematopoietic stem cell transplantation.

Inozyme Pharma 

INZ-701

FDA granted orphan drug designation for the treatment of ENPP1 deficiency.

Janssen Pharmaceutical 

Symtuza

FDA approved Symtuza for the treatment of human immunodeficiency virus type 1 in treatment-naïve and certain virologically suppressed adults.

Nohla Therapeutics 

NLA101

dilanubicel

FDA granted orphan drug designation for reduction of morbidity and mortality associated with hematopoietic stem cell transplant.

Novartis Pharmaceuticals Corp.

Kisqali ribociclib

FDA approved Kisqali in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. In combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

OBI Pharma Inc. 

OBI-3424

FDA granted orphan drug designation for the treatment of hepatocellular carcinoma.

SIGA Technologies Inc. 

TPOXX

tecovirimat

FDA approved TPOXX for the treatment of smallpox.


 

ANIMAL

There were no animal approvals to report.

Table of Contents
September 2018

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