AbbVie was granted Orphan Drug Designation by the FDA for veliparib, an oral
poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, being studied in combination with chemotherapy or radiation for the treatment of
advanced squamous non-small cell lung
PARP is a naturally-occurring enzyme
in the body that repairs damage to DNA in
cells. Researchers are investigating whether veliparib, a PARP inhibitor, in combination with DNA damaging therapies, such
as chemotherapy or radiation, may lessen
the repair of DNA damage in cancer cells,
eventually causing some cells to die.
The FDA Orphan Drug Designation
is granted to medicines intended to treat
rare diseases or disorders that affect fewer
than 200,000 people in the U.S., or that
affect more than 200,000 but are not expected to recover the costs of developing
and marketing a drug.
Novo Nordisk received approval from
the FDA for its New Drug Application for
Xultophy 100/3.6 (insulin degludec 100
units/mL and liraglutide 3. 6 mg/mL injection), a once-daily combination of Tresiba
(insulin degludec injection) and Victoza
(liraglutide) indicated as an adjunct to diet
and exercise to improve glycemic control
in type 2 diabetes. Xultophy 100/3.6 enters
a new class of diabetes treatments that
combine a basal insulin and a glucagon-like peptide-1 receptor agonist (GLP-1
RA) in a single, once-daily injection.
The approval is based on efficacy and
safety data from the DUAL (Dual Ac-
tion of Liraglutide and Insulin Degludec
in Type 2 Diabetes) clinical development
program. In three trials involving 1,393
adults with type 2 diabetes, patients who
were inadequately controlled on liraglu-
tide or basal insulin therapy and switched
to Xultophy 100/3.6 achieved reductions
in A1C. For adults uncontrolled on basal
insulin, Xultophy 100/3.6 demonstrated
significant reductions in A1C from base-
line of 1.67% and 1.94%.
GlaxoSmithKline and Innoviva have
filed a regulatory submission with the
FDA for the once-daily, closed triple
combination therapy fluticasone furoate/
100/62.5/25 mcg) for patients with chronic
obstructive pulmonary disease (COPD).
The closed triple combination therapy
comprises three medicines: fluticasone
furoate, an inhaled corticosteroid (ICS),
umeclidinium, a long-acting muscarinic
antagonist (LAMA) and vilanterol, a long-acting beta2-adrenergic agonist (LABA),
delivered once-daily in GSK’s Ellipta dry
The submission for the maintenance
treatment of patients with COPD, including chronic bronchitis and emphysema, is
based on data from the closed triple combination therapy development program,
as well as from studies with FF, UMEC and
VI either alone or in combination.
A regulatory filing in the EU is planned
in the coming weeks, as are submissions
in other countries beginning in 2017.
Janssen Biotech has submitted a Bio-
logics License Application (BLA) to the
FDA seeking approval of guselkumab for
the treatment of adults with moderate to
severe plaque psoriasis. Guselkumab is a
human monoclonal antibody that targets
interleukin (IL)- 23, a protein which has
been shown to play a key role in the de-
velopment of immune-mediated inflam-
matory diseases. Psoriasis is a chronic,
The submission is based on data from
four studies evaluating the efficacy and
safety of guselkumab administered by
subcutaneous injection in the treatment
of adults living with moderate to severe
plaque psoriasis served as the basis for the
submission. These studies include VOYAGE
1, VOYAGE 2 and NAVIGATE Phase III
studies, and the X-PLORE Phase II study.
New data from Boehringer Ingelheim’s
Phase I INVICTAN-1 study show that BI
695502, its bevacizumab biosimilar candidate, is bioequivalent to Roche’s Avastin,
an angiogenesis inhibitor used to treat
a variety of cancers and marketed in the
U.S. and EU.
BI 695502 met all the pre-defined primary and secondary endpoints in the
study. BI 695502 is a monoclonal antibody
that may slow or stop the growth of certain tumor types by preventing the growth
of blood vessels that supply the tumor.
INVICTAN-1 is a randomized, blinded,
single-dose, parallel-arm Phase I trial evaluating bioequivalence of BI 695502 to Avastin.
In the study, BI 695502 was well-tolerated
with no clinically relevant differences in
safety or immunogenicity evaluations between the BI 695502 and bevacizumab treatment groups.
Amgen and Cytokinetics achieved positive results from a Phase II trial evaluating omecamtiv mecarbil in chronic heart
failure. The trial met its primary pharma-cokinetic objective and showed statisti-
AbbVie’s Veliparib Gains Orphan
Novo Nordisk wins approval for Xultophy in type 2 diabetes