U.S. Regulatory News January 2018

index-banner-2.jpg


News of FDA drug approvals; orphan drug , fast track, and breakthrough therapy designations; and more for humans and animals.
Table of Contents
January 2018

Source: Bloomberg BNA (reports from November 6 and 13, 2017) and the Food and Drug Administration website. Compiled by Linda C. Brown, managing editor.

HUMAN |
ANIMAL

 

HUMAN

Company Trade Name Generic Name Action
Achillion Pharmaceuticals Inc. ACH-4471 FDA granted orphan drug designation for the treatment of paroxysmal nocturnal hemoglobinuria.
ArQule Inc.  Miransertib (ARQ 092) FDA granted rare pediatric disease designation for the treatment of Proteus syndrome.
AstraZeneca Pharmaceuticals LP Calquence acalabrutinib

FDA granted accelerated approval for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.

Genentech

Alecensa alectinib FDA approved Alecensa for the treatment of people with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer as detected by an FDA-approved test.
GlaxoSmithKline GSK2857916

FDA granted breakthrough therapy designation for patients who have failed at least 3 prior lines of therapy, including an anti-CD38 antibody, and are refractory to a proteasome inhibitor and an immunomodulatory agent.

Hoffman-LaRoche Inc.

Zelboraf vemurafenib FDA expands approval for the treatment of certain adult patients with Erdheim-Chester Disease.

iVeena Delivery Systems Inc.

IVMED-80

FDA granted orphan drug designation for the treatment of keratoconus.

Keryx Biopharmaceuticals Inc. Auryxia

FDA expands approval for the treatment of iron deficiency anemia in adults with chronic kidney disease.

Krystal Biotech Inc.

KB103

FDA granted orphan drug designation for the treatment of dystrophic epidermolysis bullosa.

Merck & Co. Inc. Prevymis letermovir

FDA approved Prevymis for prevention of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.

Merrimack Pharmaceuticals Inc.

Indoximod

FDA granted orphan drug designation for the treatment of heregulin positive non-small cell lung cancer.

Orphazyme A/S

Arimoclomol

FDA granted orphan drug designation for the treatment of the orphan disease Inclusion Body Myositis.

Retrotope RT001

FDA granted orphan drug designation for the treatment of PLA2G6 associated neurodegeneration.

Seattle Genetics

Adcetris

FDA approved Adcetris for the treatment of patients with cutaneous T-cell lymphoma who have received prior systemic therapy.

Valeant Pharmaceuticals International Inc.  Vyzulta latanoprostene bunod ophthalmic solution FDA approved Vyzulta for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

 

ANIMAL

Company Trade Name Generic Name Action
Elanco US Inc. Inteprity and Monteban avilamycin and narasin

FDA approved Inteprity and Monteban for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens; and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima in broiler chickens.

Elanco US Inc. Inteprity and Maxiban avilamycin, narasin, and nicarbazin

FDA approved Inteprity and Maxiban for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens; and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima in broiler chickens.


Related Stories