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Prescription medicines: Annual summary 2015
Each year, the Therapeutic Goods Administration (TGA) receives thousands of applications to register new and vary existing prescription medicines. This Annual Summary provides consolidated information on new medicines containing novel active ingredients, and significant variations that relate to new or extended therapeutic uses of a previously registered prescription medicine.
The 2015 registrations covered a broad therapeutic base, with new treatments for a number of diseases including Hepatitis C, HIV and arthritis. During this period, a first-in-class treatment for hypercholesterolaemia was approved. Notably, almost one third of these new medicines were within the fields of oncological and haematological medicine, with eleven new registrations. The approval of these new prescription medicines provides prescribers with additional treatment options, which will ultimately serve to enhance public health in Australia.
It is imperative that Australians have timely access to therapeutic goods. To this end, we have endeavoured to streamline our registration processes for prescription medicines. Performance data collected over 2015 has shown that recent reforms have delivered greater overall timeliness and predictability with respect to pre-market registration activities. On average, it takes 12 months for the TGA to register a new prescription medicine, having assessed the scientific data available and established that the medicine meets appropriate standards of quality, safety and efficacy. The TGA's approval times for medicines containing new active ingredients are comparable with analogous processes in major jurisdictions such as the US and Europe. This Annual Summary has provided us with an opportunity to increase transparency around our approval times and includes key dates in relation to the registration process for each medicine.
Our work to safeguard the health of the Australian community will continue through our post market monitoring of these products to determine how they perform when they are used more widely in the Australian population.
I hope you enjoy reading the Annual Summary and that the information continues to be useful to the Australian public, prescribers, healthcare professionals, other government agencies and industry bodies, as we work together towards better health outcomes for all Australians.
Adjunct Professor John Skerritt
Regulatory Services Group
Some innovative and 'first-in-class' new registrations
Harvoni is a combination of two anti-viral medicines (ledipasvir and sofosbuvir) used to treat hepatitis C. Harvoni is the first once-daily single tablet for the treatment of chronic hepatitis C.
Ilevro (nepafenac) is a non-steroidal anti-inflammatory eye-drop that is used to reduce the pain and inflammation resulting from cataract surgery. Ilevro passes through the cornea where it is converted to its active metabolite by enzymes in the eye. Ilevro is administered as one drop per day, starting the day before surgery and continuing for up to two weeks following surgery.
Imbruvica (ibrutininb) is used to treat patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) or mantle cell lymphoma (MCL). All of these diseases involve the proliferation of lymphocytes. Imbruvica acts by binding to a particular enzyme (Bruton's tyrosine kinase), which in turn inhibits the proliferation of B lymphocytes.
Imlygic (talimogene laherparepvec) is used to treat melanoma lesions in the skin and lymph nodes. Imlygic, a genetically modified live herpes virus, is used to treat melanoma lesions that cannot be removed completely by surgery. Imlygic is injected directly into the melanoma lesions, where it replicates inside cancer cells and causes the cells to rupture and die.
Keytruda (pembrolizumab) is used to treat unresectable (inoperable) or metastatic melanoma. Keytruda works by targeting a protein on the surface of immune cells that stops them from attacking the melanoma cells.
Optaflu is a vaccine used to prevent influenza (flu). Unlike other flu vaccines, Optaflu is produced using cultured cells rather than chicken eggs. Therefore, Optaflu is free of chicken/egg protein and is safe for use in individuals with allergies to eggs. Also, because of the manufacturing method, Optaflu can be rapidly produced during times of need such as a potential pandemic.
VIEKIRA PAK and VIEKIRA PAK-RBV
Viekira Pak is a combination pack of two different tablets. One tablet contains ombitasvir, paritaprevir and ritonavir and the other contains dasabuvir. The combination is used to treat patients with chronic hepatitis C, including those with cirrhosis. Viekira Pak can also be used in combination with the nucleoside inhibitor ribavirin in some patients (Viekira Pak-RBV).
Repatha (evolocumab) is an injection that can be used in patients who are unable to control their low-density lipoprotein (LDL) cholesterol with current treatment options such as statins, diet and exercise. Repatha is an antibody that binds and blocks a specific protein (PCSK9), which reduces the ability of the liver to remove LDL cholesterol from the blood. By blocking PCSK9, the liver is more able to get rid of LDL cholesterol from the blood.
Selincro (nalmefene) is used in association with counselling, to reduce high levels of alcohol consumption in patients with alcohol dependence. Selincro is a tablet that is taken once a day and works by affecting processes in the brain that are responsible for the urge to continue drinking.
Trulicity (dulaglutide) is a once-weekly subcutaneous injection used, together with diet and exercise, to improve blood sugar levels in patients with type 2 diabetes. Trulicity acts by mimicking the naturally occurring peptide, glucagon, a hormone that helps to control blood sugar levels.
Some new or extended uses for existing medicines
Patients will also benefit from the approval of existing prescription medicines for new or extended therapeutic uses. From mid-2016, details relating to new or extended uses of registered prescription medicines will be published on the TGA website.
Cortiment (budesonide) is a corticosteroid available in different preparations for the treatment of various inflammatory diseases including ulcerative colitis (UC). Budesonide is absorbed relatively poorly from the gut when given orally which has the advantage of causing less systemic side-effects than other oral corticosteroids. Cortiment dissolves slowly in the gut and continues to release the active ingredient as it passes through the large intestine where it can act locally at the site of disease.
A new, prolonged-release budesonide tablet has been approved for short term use which will now include induction of remission in patients with mild to moderate ulcerative colitis.
Eliquis (apixaban) has been registered since 2011 for the prevention of blood clots following hip and knee replacement surgery and for the prevention of blood clots and stroke in patients with atrial fibrillation.
Eliquis is now indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for prevention of recurrent DVT and PE in adults.
Enbrel (etanercept) has been registered since 2003 for the treatment of inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.
Enbrel is now indicated for use in adult patients with active non-radiographic axial spondyloarthritis (a form of ankylosing spondylitis that cannot be detected on an X-ray) and is the first medicine to be specifically approved for this condition.
Kineret (anakinra) has been registered since 2003, in combination with methotrexate, for the treatment of rheumatoid arthritis.
Kineret is now also indicated for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in children aged two years and above.
Pradaxa (dabigatran) has been registered since 2008 for the prevention of blood clots following major total hip or knee replacement and for prevention of stroke and blood clots in patients with atrial fibrillation.
Pradaxa is now indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults.
Liraglutide has been registered since 2010, in combination with other medicines, for the treatment of patients with type 2 diabetes.
Saxenda is a new presentation of liraglutide that is approved for use in chronic weight management in obese or overweight patients, in conjunction with a reduced-calorie diet and increased physical activity.
Spiriva (tiotropium) has been registered since 2002 for the treatment and prevention of bronchospasms associated with chronic obstructive pulmonary disease.
Spiriva is now approved for use as an add-on bronchodilator in adult asthma patients, in addition to existing inhaled corticosteroids and β2-agonists.
Stelara (ustekinumab) has been registered since 2009 for the treatment of plaque psoriasis.
Stelara is now approved for the treatment of psoriatic arthritis in adult patients where other treatments have been inadequate. Stelara may be used alone or in combination with methotrexate.
Stribild has been registered since 2013 as a first line treatment for HIV infection. It is an oral antiviral medicine consisting of a combination of four active ingredients (tenofovir disoproxil fumarate, emtricitabine, elvitegravir and cobicistat).
Stribild can now be used in HIV infected patients who have already been stabilised on other antiviral treatments, thereby potentially replacing multiple medicines with a single, once-daily tablet.
New registrations by therapeutic area
Cardiovascular, Metabolic and Musculoskeletal disorders
CARBAGLU carglumic acid
CERDELGA eliglustat (as tartrate)
RENVELA sevelamer carbonate
REPATHA evolocumab (rch)
XELJANZ tofacitinib (as citrate)
Antidotes, Analgesics and Neurological Agents
SELINCRO nalmefene (as hydrochloride dihydrate)
Immunomodulators, Antineoplastics and Antiemetic Agents
AKYNZEO netupitant/palonosetron (as hydrochloride)
BLINCYTO blinatumomab (rch)
COSENTYX secukinumab (rch)
IMLYGIC talimogene laherparepvec
LONQUEX lipegfilgrastim (rbe)
ODOMZO sonidegib diphosphate
OFEV nintedanib (as esilate)
SYLVANT siltuximab (rmc)
Endocrine, Gynaecological, Fluid and Electrolyte Agents
ALBUNATE 20 human albumin
DECAPEPTYL triptorelin acetate
ELLAONE ulipristal acetate
TRULICITY dulaglutide (rch)
Anti-Infectives and Vaccines
DAKLINZA daclatasvir (as dihydrochloride)
GARDASIL 9 human papillomavirus 9-valent vaccine
OPTAFLU inactivated influenza virus vaccine
VIEKIRA PAK paritaprevir/ritonavir/ombitasvir and dasabuvir (as sodium salt)
VIEKIRA PAK-RBV paritaprevir/ritonavir/ombitasvir and dasabuvir (as sodium salt) and ribavirin
ZERBAXA ceftolozane sulfate/tazobactam sodium
ZEVTERA ceftobiprole medocaril sodium