Company |
Product |
Description |
Indication |
Status |
Date |
Allergan Inc. (Irvine, Calif.) |
Botox Cosmetic |
Onabotulinum-toxinA |
Moderate to severe lateral canthal lines (crow’s feet) |
FDA approved it |
9/12/13 |
Astrazeneca plc (London) and Bristol-Myers Squibb Co. (New York) |
Dapaglivlozin |
Add-on therapy to metformin plus sulfonylurea |
Diabetes |
Phase III data showed it produced significant improvements in glycosylated hemoglobin levels, significant reductions in fasting plasma glucose and reductions in body weight compared to placebo after 24 weeks of treatment |
9/25/13 |
Astrazeneca plc (London) and Bristol-Myers Squibb Co. (New York) |
Onglyza |
Saxagliptin |
Type II diabetes |
Met the primary safety objective, compared to placebo, demonstrating no increased risk for the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction or nonfatal ischemic stroke when added to standard of care; a greater percentage of Onglyza patients reached target levels of HbA1c without hypoglycemia, except for those treated with sulfonylureas alone at baseline |
9/4/13; 9/27/13 |
Bayer AG (Leverkusen, Germany) |
Adempas |
Riociguat |
Persistent or recurrent chronic thromboembolic pulmonary hypertension |
Received Health Canada approval |
9/24/13 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Giotrif |
Afatinib |
Locally advanced or metastatic non-small-cell lung cancer |
European Commission granted marketing authorization |
9/26/13 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Respimat |
Once-daily olodaterol |
Chronic obstructive pulmonary disease |
Phase III data showed it maintained lung function improvements and demonstrated rapid onset of action within five minutes after the first dose |
9/10/13 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Tradjenta |
Dipeptidyl peptidase-4 inhibitor linagliptin |
Type II diabetes |
A pooled analysis of 22 trials and 7,400 people showed the drug was well tolerated |
9/25/13 |
Bristol-Myers Squibb Co. (New York) and Pfizer Inc. (New York) |
Eliquis |
Apixaban |
To prevent stroke or systemic embolism in nonvalvular atrial fibrillation |
Phase III data showed lower rates of stroke or systemic embolism and of major bleeding in patients randomized to Eliquis compared to those randomized to warfarin |
9/4/13 |
Bristol-Myers Squibb Co. (New York) |
Yervoy |
Anti-CTLA-4 drug; ipilimumab |
Prostate cancer |
Phase III failed to reach statistical significance, with Yervoy patients living an average of 11.2 months, compared with 10 months for placebo patients |
8/13/13 |
Celator Pharmaceuticals Inc. (Ewing, N.J.) |
CPX-351 |
Cytarabine: daunorubicin liposome injection |
Hematologic malignancies |
First patient was enrolled in a study that includes dose exploration and expanded phases to assess pharmacokinetics, toleraiblity and early evidence of efficacy |
9/23/13 |
CSL Behring (King of Prussia, Pa.) |
Hizentra |
Immune globulin subcutaneous (human) |
Primary and secondary immunodeficiency |
Approved in Japan |
9/30/13 |
Daiichi Sankyo Co. Ltd. (Tokyo) |
Edoxaban |
Oral, once-daily direct Factor Xa inhibitor |
Deep vein thrombosis and/or pulmonary embolism |
Phase III data showed it met the primary efficacy endpoint of noninferiority compared to warfarin, following initial use of heparin in both arms |
9/4/13 |
Eli Lilly and Co. (Indianapolis) |
Dulaglutide |
Long-acting glucagon-like peptide 1 receptor agonist |
Type II diabetes |
Phase III data showed reductions in HbA1c levels and weight at 26 weeks and 52 weeks |
9/27/13 |
Endo Pharmaceuticals Inc. (Malvern, Pa.) |
Aveed |
A long-acting testosterone undecanoate injection |
Hypogonadism |
FDA accepted a complete response submission |
9/6/13 |
Endo Pharmaceuticals Inc. (Malvern, Pa.) and Biodelivery Sciences International Inc. (Raleigh, N.C.) |
BEMA |
Buprenorphine/naloxone formulation |
Pain |
Interim Phase III data showed no sample size adjustment will be necessary for the opioid-arm of the study; additional patients will be added to the opioid-experienced arm |
9/5/13 |
Forest Laboratories Inc. (New York) |
Ceftazidime/avibactam |
Drug to treat infections |
Intra-abdominal infections and complicated urinary tract infections, and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia |
Forest received Qualified Infectious Disease Product designation from the FDA |
9/16/13 |
Hospira Inc. (Lake Forest, Ill.) |
Inflectra |
Infliximab; biosimilar of Remicade |
Rheumatoid arthritis |
European Union granted approval |
9/11/13 |
Ipsen SA (Paris) |
Somatuline Autogel/Somatuline Depot |
Lanreotide injection 120 mg |
Neuroendocrine tumors associated with carcinoid syndrome |
Treatment with Somatuline was found to be statistically significantly superior to placebo in decreasing the number of days patients needed to use rescue medication to control symptoms |
9/18/13 |
Janssen Biologics BV (Leiden, the Netherlands) |
Simponi |
Golimumab |
Moderately to severely active ulcerative colitis |
European Commission approved Simponi |
9/24/13 |
Janssen-Cilag International NV (Beerse, Belgium; part of Johnson & Johnson) |
Invokana |
Canagliflozin; oral, once-daily sodium glucose co-transporter 2 inhibitor |
Type II diabetes |
EMA’s CHMP recommended approval; showed substantial improvements in glycemic control in a Phase III trial |
9/23/13; 9/25/13 |
Janssen-Cilag International NV (Beerse, Belgium; part of Johnson & Johnson) |
Stelara |
Ustekinumab |
Psoriatic arthritis |
European Commission approved the use of Stelara |
9/24/13 |
Janssen Pharmaceuticals Inc. (Raritan, N.J.; part of Johnson & Johnson) |
Xarelto |
Rivaroxaban |
Deep vein thrombosis |
A pooled analysis of the Phase III program showed it is as effective as standard of care in reducing the risk of deep vein thrombosis and pulmonary embolism while reducing the incidence of major bleeding by 46% |
9/23/13 |
Janssen Research & Development LLC (Raritan, N.J.) |
Siltuximab |
Targets interleukin-6 |
Castleman disease |
Submitted a BLA to the FDA and an MAA to the EMA |
9/4/13 |
Mallinckrodt Pharmaceuticals (St. Louis) |
MNK-795 |
A controlled-release oral formulation of oxycodone and acetaminophen |
Acute pain following bunionectomy |
Phase III data showed statistically significant improvement in pain scores compared to placebo from baseline over 48 hours |
9/6/13 |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Corifollitropin alfa |
Fertility treatment |
For use with assisted reproductive technology |
An NDA was submitted and accepted for standard review |
9/10/13 |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Sugammadex |
A next-generation anesthesia reversal agent |
For use in anesthesiology |
FDA issued a complete response letter |
9/24/13 |
Novartis AG (Basel, Switzerland) |
QVA149 |
Indacaterol 85 mcg/glycopyrronium 43 mcg |
Chronic obstructive pulmonary disease |
Showed clinically significant improvements in lung function, shortness of breath and health-related quality of life |
9/10/13 |
Otsuka Pharmaceutical Co. Ltd. (Tokyo) and H. Lundbeck A/S (Copenhagen) |
Abilify Maintena |
Aripiprazole; an intramuscular depot formulation |
Schizophrenia |
EMA’s CHMP recommended marketing authorization |
9/23/13 |
Perrigo Co. (Allegan, Mich.) |
Nitrolingual Pumpspray |
Nitroglycerin lingual spray |
Angina pectoris due to coronary artery disease |
FDA approved an abbreviated NDA |
9/24/13 |
Sunovion Pharmaceuticals Inc. (Marlborough, Mass.) |
Eslicarba-zepine acetate |
Monotherapy |
Partial-onset seizures |
Completed two Phase III trials |
9/18/13 |
Takeda Pharmaceuticals International GmbH (Zurich, Switzerland) |
Alogliptin |
|
Type II diabetes and acute coronary syndrome |
Data indicated it did not increase cardiovascular ischemic events, including all-cause mortality, nonfatal myocardial infarction, nonfatal stroke and urgent revascularization due to unstable angina |
9/27/13 |
Teva Pharmaceutical Industries Ltd. (Jerusalem) |
Nuvigil |
Armodafinil |
Major depression associated with bipolar I disorder |
The final Phase III study of Nuvigil failed to achieve the primary endpoint of determining whether armodafinil (150 mg per day) is more effective than placebo as adjunct therapy to mood stabilizers and/or atypical antipsychotics |
9/3/13 |
Teva Pharmaceutical Industries Ltd. (Jerusalem) |
Xeloda |
Generic capecitabine; an oral chemotherapy pill |
Metastatic colorectal and metastatic breast cancers |
FDA approved it |
9/17/13 |
Notes: The date indicated refers to the BioWorld Today issue in which the news item can be found. |